Drug News Update
Sovaldi Approved for Hepatitis C
The FDA has approved Gilead’s Sovaldi (sofosbuvir) oral tablets for the treatment of chronic hepatitis C virus infection in adults. Sovaldi is to be used as a component of a combination antiviral treatment regimen for chronic HCV infection including Sovaldi and ribavirin or Sovaldi, ribavirin, and peginterferon-alfa.
Expanded Indication for Xiaflex
The FDA has approved Auxilium Pharmaceuticals’ Xiaflex (collagenase clostridium histolyticum) injection solution for the treatment of Peyronie disease in men. Xiaflex is the first FDA-approved medicine for this indication. Xiaflex is also indicated for the treatment of adult patients with Dupuytren contracture with palpable cord.
Onfi Safety Alert
The FDA is warning the public that Lundbeck’s Onfi (clobazam) can cause rare but serious skin reactions called Stevens-Johnson syndrome and toxic epidermal necrolysis that can result in permanent harm and death. The FDA approved changes to the Onfi drug label and the patient Medication Guide to describe the risk of these serious skin reactions. Onfi is a benzodiazepine medication used in combination with other medicines to treat seizures associated with a severe form of epilepsy called Lennox-Gastaut Syndrome. Health care providers should monitor patients closely for signs and symptoms of skin reactions, especially during the first 8 weeks of treatment and encourage patients to seek immediate medical treatment if they develop a rash, blistering or peeling of the skin, sores in the mouth, or hives.
Baxter Recalls Nitroglycerin in 5% Dextrose Injection
Baxter International is voluntarily recalling 1 lot (G105197) of nitroglycerin in 5% dextrose injection packaged in 250 mL glass containers due to particulate matter found in 1 vial. Any available product should be immediately quarantined.
The affected lot was distributed to customers between January 17, 2013, and October 10, 2013. Product returns can be arranged by contacting Baxter at 1-888-229-0001 between 7:00 AM and 6:00 PM CST.
Abbott Recalls FreeStyle and FreeStyle Lite Test Strips
Abbott is initiating a voluntary US recall of 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips because they may produce erroneously low blood glucose results when used with the FreeStyle Blood Glucose Meter, FreeStyle Flash Blood Glucose Meter (not produced since 2010), and the OmniPod Insulin Management System. When the test strips are used with the newer FreeStyle-brand meters including FreeStyle Freedom Blood Glucose Meter, FreeStyle Lite Blood Glucose Meter, and FreeStyle Freedom Lite Blood Glucose Meter, the test results are not affected. The affected test strips have expiration dates between May 2014 and March 2015:
Abbott is notifying health care providers, pharmacies, distributors, and customers about the recall. Customers affected by this recall can call 1-888-736-9869 for a replacement at no charge.
FDA Approves Velphoro
The FDA has approved Galenica’s Velphoro (sucroferric oxyhydroxide) tablets for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. Velphoro will be launched in the US by Fresenius Medical Care North America in 2014.
FDA Approves Varithena for Varicose Veins
The FDA has approved BTG’s Varithena (polidocanol) injectable foam for the treatment of patients with incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein system above and below the knee. Varithena improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. The company plans to launch the product in the US in the second quarter of 2014.
Hydroxyethyl Starch Solutions Updated Boxed Warning
The FDA has updated the Box Warning to the labeling for hydroxyethyl starch (HES) solutions to include the following:
- Monitor the coagulation status of patients undergoing open heart surgery in association with cardiopulmonary bypass as excess bleeding has been reported with hydroxyethyl starch solutions.
- Do not use hydroxyethyl starch products in patients with severe liver disease.
- Monitor liver function in patients receiving hydroxyethyl starch products.
FDA Recommendations for Health Professionals also included:
- Do not use hydroxyethyl starch solutions in critically ill adult patients, including those with sepsis and those admitted to the intensive care unit.
- Avoid use in patients with preexisting renal dysfunction.
- Discontinue use of hydroxyethyl starch at the first sign of renal injury.
- Need for renal replacement therapy has been reported up to 90 days after hydroxyethyl starch administration. Continue to monitor renal function for at least 90 days in all patients.
- Avoid use in patients undergoing open heart surgery in association with cardiopulmonary bypass due to excess bleeding.
- Discontinue use of hydroxyethyl starch at the first sign of coagulopathy.
Hydroxyethyl starch solutions are indicated for the treatment of hypovolemia when plasma volume expansion is desired. Voluven (Hospira) is also indicated for the prophylaxis of hypovolemia when plasma volume expansion is desired. Hespan (B. Braun) is also indicated as an adjunct in leukapheresis to improve harvesting and increase yield of granulocytes by centrifugal means.
FDA Removes Some Restrictions for Rosiglitazone-Containing Medicines
The FDA is requiring the removal of prescribing and dispensing restrictions that were put in place in 2010 for rosiglitazone medicines such as Avandia, Avandamet, Avandaryl, and generics. The change is based on recent data that did not show an increased risk of heart attack compared with the standard type 2 diabetes drugs metformin and sulfonylureas. The current rosiglitazone Risk Evaluation and Mitigation Strategy (REMS) and patient Medication Guide will also be modified.http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm376683.htm
FDA Approves Aptiom for Seizures
The FDA has approved Sunovion Pharmaceuticals’ Aptiom (eslicarbazepine acetate) tablets for adjunctive therapy in the treatment of partial-onset seizures in patients 18 years and older with epilepsy. Aptiom will be dispensed with a patient Medication Guide.
FDA Approves Olysio
The FDA has approved Janssen Therapeutics’ Olysio (simeprevir) capsules for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1–infected adults with compensated liver disease, including cirrhosis. Olysio may benefit patients with chronic hepatitis C, including those who are treatment naive or in whom prior interferon-based therapy failed.
FDA Approves First Adjuvanted Vaccine to Prevent Avian Influenza
The FDA has approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. Influenza A (H5N1) virus monovalent vaccine, adjuvanted, is for use in people 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus. This H5N1 avian influenza vaccine is not intended for commercial availability. The U.S. Department of Health and Human Services purchased the vaccine from the manufacturer, ID Biomedical Corporation of Quebec, Quebec City, Canada, a subsidiary of GlaxoSmithKline Biologicals, for inclusion within the National Stockpile for distribution by public health officials, if needed.
For additional information, please refer the FDA’s website.
Expanded Indication for Nexavar
The FDA has approved Bayer HealthCare’s Nexavar (sorafenib) tablets for the treatment of late-stage metastatic differentiated thyroid cancer refractory to radioactive iodine treatment. Nexavar is also indicated for the treatment of patients with advanced renal cell carcinoma, as well as for the treatment of patients with unresectable hepatocellular carcinoma.
FDA Approves Luzu Cream
The FDA has approved Valeant Pharmaceuticals North America’s Luzu (luliconazole 1%) cream for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis in patients 18 years and older.
Nature’s Pharmacy and Compounding Center Sterile Product Recall
Nature’s Pharmacy and Compounding Center of Asheville, NC, is voluntarily recalling at the consumer level all lots of sterile products compounded by the pharmacy in the form of an injectable drug or an eye drop that are not expired. The recall is being initiated because of concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
The products were supplied to the offices of licensed medical providers and to patients by prescription within the pharmacy’s local market area in North Carolina. They were distributed from January 1, 2013, to present.
Medical providers, clinics, and patients who have these products should stop their use and return them to the place of purchase. Clinics should contact any patient that has received treatment using any of these sterile products. Consumers or health care providers with questions regarding this recall may contact Nature’s Pharmacy at 1-828-251-0094 or toll-free at 1-800-645-8201, Monday through Friday, 9:30 AM to 6 PM EST, or by email at email@example.com.
FDA Safety Communication: Changes to Reduce Infection Risk with Over-the-Counter Topical Antiseptics
Based on reports of outbreaks associated with the use of contaminated over-the-counter (OTC) topical antiseptics, the FDA is requesting labeling and packaging changes to certain OTC topical antiseptic products indicated for preoperative or preinjection skin preparation. Although currently available as single- or multiuse products, the FDA is requesting that these antiseptics now be packaged for single-use only. The request is the result of the FDA’s ongoing evaluation of infrequent, but continuing, reports ranging from localized infections at injection sites to systemic infections resulting in death. The FDA has reviewed reports of 4 deaths; 5 cases of wound infection; 7 cases of peritonitis; 10 cases of septic arthritis; 14 cases of indwelling catheters requiring replacement; 16 cases of injection site infection; and 32 cases of bacteremia, all confirmed to be caused by contaminated antiseptic products. Affected products include all commonly used antiseptic ingredients including alcohol, iodophors, chlorhexidine gluconate, and quaternary ammonium products. Organisms implicated in the outbreaks include Bacillus cereus, Burkholderia cepacia, Pseudomonas aeruginosa, Achromobacter xylosoxidans, Ralstonia pickettii, Serratia marcescens, and Mycobacterium abscessus. When used properly, topical antiseptics are safe and effective for preoperative or preinjection use. However contamination of topical antiseptics most often occurs when organisms are introduced into the product by users.
The FDA recommends the following safety measures:
- To reduce the risk of infection, ensure the products are used according to the directions on the label.
- The antiseptics in these single-use containers should be applied only 1 time to 1 patient.
- Avoid diluting antiseptic products after opening them.
- Applicators and any unused solution should be discarded after the single application.
Further information may be found at the following website: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm374892.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.
Aptiom Approved for Seizures in Adults
The FDA has approved Sunovion Pharmaceuticals’ Aptiom (eslicarbazepine acetate) as adjunctive therapy for the treatment of partial seizures in patients with epilpesy. Aptiom will be dispensed with a patient Medication Guide.
FDA Approves Imbruvica
The FDA has approved Phamacyclis’ and Janssen Biotech’s Imbruvica (ibrutinib) for the treatment of patients with mantle cell lymphoma (MCL). Imbruvica is intended for patients with MCL who have received at least 1 prior therapy and was approved under the FDA’s accelerated approval program.
OxyElite Pro Dietary Supplement Recalled
- OxyElite Pro Super Thermo capsules
- two count capsules UPC #094922417275
- 10 count capsules UPC #094922417251
- 10 count capsules UPC #094922417268
- 21 count capsules UPC #094922426604
- 90 count capsules UPC #094922395573
- 90 count capsules “Pink label” UPC #094922447906
- 180 count capsules UPC #094922447852
- OxyElite Pro Ultra-Intense Thermo capsules
- three count capsules UPC #094922447883
- three count capsules UPC #094922447876
- 90 count capsules UPC #094922395627
- 180 count capsules UPC #094922447869
- OxyElite Pro Super Thermo powder
- Fruit Punch 0.15 oz UPC #094922417237
- Fruit Punch 0.15 oz UPC #094922447517
- Fruit Punch 4.6 oz UPC #094922426369
- Fruit Punch 5 oz. UPC #094922447487
- Blue Raspberry 4.6 oz UPC #094922426376
- Grape Bubblegum 4.6 oz UPC #094922447500
- Green Apple 4.6 oz. UPC #094922426499
In addition to the recalled products, the FDA is advising consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1. Consumers who believe they have been harmed by using a dietary supplement should contact their health care provider. Consumers can contact USPlabs at 1-800-890-3067, Monday through Friday, 9 AM to 5 PM EST or firstname.lastname@example.org.
FDA Approves Generic Aciphex Tablets
The FDA has approved Mylan’s rabeprazole sodium 20 mg delayed-release tablets, the generic version of Aciphex, indicated for the short-term treatment of erosive or ulcerative gastroesophageal reflux disease (GERD) and duodenal ulcers.
FDA Approves Juvederm Voluma XC for Volume Loss in Cheek Area
The FDA has approved Allergan’s Juvederm Voluma XC (hyaluronic acid [with lidocaine]) injectable gel for the treatment of volume loss in the cheek area.
Safety Announcement for Low Molecular Weight Heparins
The FDA has announced upcoming changes to be made to the product labeling for enoxaparin (Lovenox) and other low molecular weight heparins (LMWHs).The FDA recommends that health care providers carefully consider the timing of spinal catheter placement and removal in patients receiving these drugs, and to delay dosing for a period of time after catheter removal to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and lumbar punctures. Prior to catheter placement or removal, health care providers should determine whether a patient is receiving a LMWH and identify the appropriate timing of LMWH dosing. To reduce the potential risk of bleeding, both the dose and elimination half-life of the drug should be considered. The following recommendations have been made for enoxaparin:
- Placement or removal of a spinal catheter should be delayed for at least 12 hours after administration of prophylactic doses such as those used for prevention of deep vein thrombosis. Longer delays (24 hours) are appropriate to consider for patients receiving higher therapeutic doses (1 mg/kg twice daily or 1.5 mg/kg once daily).
- A postprocedure dose should usually be given no sooner than 4 hours after catheter removal.
- In all cases, a benefit-risk assessment should consider both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors.
It is important to note that all anticoagulants carry the risk of causing spinal bleeding when used in conjunction with epidural/spinal anesthesia or spinal puncture. The FDA is continuing to evaluate the safety of other anticoagulants to determine if additional label changes are needed. Before undergoing an epidural or spinal procedure, patients should be advised to inform their health care provider if they are taking any anticoagulant drugs. When undergoing these types of procedures, patients should alert their health care provider immediately if they experience any symptoms such as numbness, tingling, leg weakness or paralysis, or loss of control of their bladder or bowels.
Further information is available here.
FDA Approves NovoLog FlexTouch and Levemir FlexTouch
The FDA has approved Novo Nordisk’s NovoLog (insulin aspart) FlexTouch and Levemir (insulin detemir) FlexTouch prefilled insulin pens.
The dosing mechanism of FlexTouch ensures the push-button does not extend at any dose and allows insulin to be administered by pressing the low-dose force button.
Novo Nordisk plans to make NovoLog FlexTouch and Levemir FlexTouch available in the US within the next year.
New Boxed Warning for Ofirmev
The FDA has approved a new Boxed Warning for Cadence Pharmaceuticals’ Ofirmev (acetaminophen) injection alerting health care providers to the risk of medication errors that may result in accidental overdose. The revised labeling also includes a warning regarding hepatotoxicity. Ofirmev is indicated for the management of mild to moderate pain and the management of moderate to severe pain with adjunctive opioid analgesics, as well as for the reduction of fever.
Acetaminophen Infant Suspension Recall
The Perrigo Company is voluntarily recalling 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2- and 4-ounce bottles with syringes in a box under store brand products including Babies R Us, Care One, and others, because a small number of packages might contain an oral dosing syringe without dose markings. The syringe should have a white or yellow plunger with specific dose markings for 1.25, 2.5, 3.75, and 5 mL. If the syringe has these dose markings, it is safe to use the product while following labeled instructions. Using an oral syringe without dose markings can result in in infants mistakenly receiving an inappropriately high dose.
If a package contains an oral dosing device without dose markings, do not use the product and contact Perrigo’s Consumer Affairs Department at 1-800-719-9260 for further instructions. Consumers should contact their health care provider if they have any questions or problems that could possibly be related to this product.
For more information, see Perrigo’s website.
FDA Approves Gazyva for Chronic Lymphocytic Leukemia
The FDA has approved Genentech’s Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia. Gazyva is the first drug with breakthrough therapy designation to receive FDA approval.
Gazyva carries a Boxed Warning regarding hepatitis B virus reactivation and progressive multifocal leukoencephalopathy. Patients should be advised of these risks and assessed for hepatitis B virus and reactivation risk.
Incivek Label Changes
The FDA has approved label changes specifying new dosing recommendations for Incivek (telaprevir) from 750 mg every 8 hours to 1,125 mg twice daily (every 10 to 14 hours).
Potiga Linked to Retinal Abnormalities and Skin Discoloration
The FDA has approved labeling changes for the anti-seizure drug Potiga (ezogabine), underscoring risks of eye abnormalities characterized by pigment changes in the retina, including scleral and conjunctival discoloration on the whites of the eyes and inside of eyelids, and can also cause blue skin discoloration, predominantly on or around the lips or in the nail beds of fingers or toes, although more widespread involvement of the face and legs has also been reported. The skin discoloration generally occurred after 4 years of treatment, but appeared sooner in some patients. In some cases, retinal abnormalities were observed in the absence of skin discoloration. The FDA does not currently know if these changes are reversible, the typical onset or rate of progression, or which patient populations may be at an increased risk for ocular abnormalities.
The FDA advises that the use of ezogabine be limited to patients who have not responded adequately to several alternative therapies and for whom the benefits of treatment outweigh the risks. All patients taking ezogabine should undergo a baseline eye exam and periodic eye exams every 6 months that include visual acuity testing and dilated fundus photography. Fluorescein angiograms, ocular coherence tomography, perimetry, and electroretinograms may also be considered. Patients whose vision cannot be monitored should generally not take ezogabine.
Patients who develop changes in vision or skin discoloration should contact their healthcare provider immediately. If retinal pigmentary abnormalities or vision changes are detected, ezogabine should be stopped unless no other suitable seizure treatment options are available and the benefits of treatment outweigh the potential risk of vision loss. Health care professionals should discontinue ezogabine treatment in patients who do not show substantial clinical benefit after adequate dose titration. Patients should not stop taking the drug without first discussing their treatment with their health care professionals.
Safety Warning for Iclusig
The FDA has asked Ariad Pharmaceuticals to suspend marketing and sales of Iclusig (ponatinib) due to the risk of life-threatening blood clots and severe narrowing of blood vessels.
Iclusig is indicated for the treatment of adult patients with Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy, as well as for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy.
Patients currently receiving Iclusig should discuss with their health care professionals the risks and benefits of continuing treatment with the drug. At this time, patients and health care professionals should adhere to the following FDA recommendations while the agency continues to evaluate the drug’s safety:
- Patients currently taking Iclusig who are not responding to the drug should immediately discontinue treatment and discuss alternative treatment options with their health care professionals.
- Patients who are currently taking Iclusig and responding to the drug and whose health care professionals determine that the potential benefits outweigh the risks should be treated under a single-patient Investigational New Drug (IND) application or expanded access registry program while FDA’s safety investigation continues. FDA will work with the manufacturer on a plan to quickly transition these patients to a program that will allow access under an IND or expanded access registry program. Patients: For more information on access to treatment under an IND, please refer to this website.
- Health care professionals should not start treating new patients with Iclusig unless no other treatment options are available and all other available therapies have failed. Upon the determination of their health care professional, these patients can be considered for treatment under an IND or expanded access registry program. Health care professionals: For more information on obtaining access to treatment for your patient under an IND, please refer to this website.
For more information on the FDA’s investigation see the previous story.
FDA Approves Generic Fosrenol
The FDA has approved Prasco’s lanthanum carbonate 500, 750, and 1,000 mg chewable tablets, the generic version of Fosrenol, indicated to reduce serum phosphate in patients with end-stage renal disease. Prasco has an exclusive distribution and supply agreement with Shire for this authorized generic version of lanthanum carbonate, meaning Shire continues to produce the product but markets it under the Prasco private label at generic prices.
FDA Approves Vizamyl for Beta-Amyloid Detection
The FDA has approved GE Healthcare’s Vizamyl (flutemetamol F18) injection, a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain, to estimate beta- amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer disease and other causes of cognitive decline.
Expanded Indication for Sabril
The FDA has approved Lundbeck’s Sabril (vigabatrin) as add-on therapy for the treatment of refractory complex partial seizures (CPS) in children 10 years and older who have inadequately responded to several other treatments and if the possible benefit outweighs the risk of vision loss. Sabril is currently approved for use as monotherapy in infants and children 1 month to 2 years of age with infantile spasms and as adjunctive therapy for adults with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the potential risk of vision loss. Sabril is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) and is dispensed with a patient Medication Guide.
FDA Approves Ecoza for Tinea Pedis
The FDA has approved AmDerma’s Ecoza (econazole nitrate) topical foam 1% for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years and older.
FDA to Recommend Schedule Change for Hydrocodone Products
Due to increasing concerns about the abuse and misuse of opioid products, the FDA has been challenged with determining how to balance the need to ensure ongoing access for patients who rely on continuous pain relief while addressing these concerns.
In 2009, the US Drug Enforcement Administration (DEA) asked the US Department of Health and Human Services (HHS) for a recommendation regarding whether to change the schedule for hydrocodone combination products (eg, hydrocodone and acetaminophen [Vicodin]) from Schedule III to Schedule II, thereby increasing the controls on these products. As a result, by early December 2013 the FDA plans to submit a formal recommendation to the HHS to reclassify hydrocodone combination products as Schedule II drugs. It is likely that the National Institute on Drug Abuse will concur with the recommendation, beginning a process that will lead to a final scheduling decision by the DEA.
Expanded Indication for Exelon Patch
The FDA has approved Novartis’ Exelon (rivastigmine) patch for the treatment of severe dementia in patients with Alzheimer disease. Exelon is also approved for the treatment of mild to moderate dementia in patients with Alzheimer disease, as well as treatment of mild to moderate dementia associated with Parkinson disease.
FDA Approves Zohydro ER for Severe Pain
The FDA has approved Zogenix’s Zohydro ER (hydrocodone bitartrate, Schedule II) single-entity, extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. The FDA is requiring postmarketing studies of Zohydro ER to assess the known serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with long-term use beyond 12 weeks.
Zohydro ER will be part of the extended-release/long-acting opioid analgesics Risk Evaluation and Mitigation Strategy (REMS) and will be dispensed with a patient Medication Guide.
Next Choice One Dose Recall
Watson Laboratories has issued a voluntary recall of 2 lots (580974AA and 580975AA, expiration date September 2014) of Next Choice One Dose (levonorgestrel) emergency contraceptive 1.5 mg tablets because of multiple complaints of pushthrough tablet breakage in blister packs.
Expanded Boxed Warning for Entereg
The FDA has expanded the Boxed Warning for Cubist Pharmaceuticals’ Entereg (alvimopan) to include information about the potential risk of myocardial infarction with long-term use. Entereg is currently available only through a restricted program for short-term use under a Risk Evaluation and Mitigation Strategy (REMS) and is dispensed with a patient Medication Guide.
FDA Approves Zorvolex for Acute Pain
The FDA has approved Iroko Pharmaceuticals’ nonsteroidal anti-inflammatory drug Zorvolex (diclofenac) for the treatment of mild to moderate acute pain in adults. Zorvolex capsules were approved at dosage strengths 20 percent lower than those of currently available diclofenac products. Zorvolex carries a Boxed Warning regarding the increased risk of serious cardiovascular and gastrointestinal events, and is dispensed with a patient Medication Guide.
Opsumit Approved for Pulmonary Arterial Hypertension
The FDA has approved Actelion Pharmaceuticals’ Opsumit (macitentan) tablets for the treatment of pulmonary arterial hypertension in adults. Opsumit, an endothelin receptor blocker, carries a Boxed Warning contraindicating its use in pregnant women due to the risk of embryo-fetal toxicity. Opsumit will be available to women only through the Opsumit Risk Evaluation and Mitigation Strategy (REMS) Program, a restricted-distribution program requiring prescribers to be certified by enrolling in the program. It also requires all female patients to be enrolled in the program and to comply with applicable pregnancy testing and contraception requirements before initiating treatment, as well as for pharmacies to be certified and to dispense Opsumit only to patients who are authorized to receive it.
Cimzia Approved for Ankylosing Spondylitis
The FDA has approved UCB’s Cimzia (certolizumab pegol) for the treatment of adults with active ankylosing spondylitis. Cimzia is currently approved in adults for the treatment of active psoriatic arthritis as well as for moderately to severely active rheumatoid arthritis and Crohn disease. A Boxed Warning concerning the risk of serious infections and malignancy is included in Cimzia’s labeling, and the drug is dispensed with a patient Medication Guide.
FDA Approves Novoeight for Hemophilia
The FDA has approved Novo Nordisk’s Novoeight (antihemophilic factor [recombinant]) injection for adults and children with hemophilia A to control and prevent bleeding, for perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Novoeight will be launched with the newly introduced prefilled device MixPro and is expected to be available after April 2015.
Antivenin (Micrurus fulvius) Expiration Date Extended
Wyeth Pharmaceuticals (a subsidiary of Pfizer) has extended the expiration date of 1 lot (4030024) of antivenin (Micrurus fulvius) through April 30, 2014. Wyeth had previously extended the expiration date of another lot (4030026) of antivenin (Micrurus fulvius) to October 31, 2013, which is now also extended to 2014. Any remaining inventory of either lot (4030024 or 4030026) should be retained until their respective expiration dates because Pfizer supplies product only to direct customers on a replacement or emergency basis due to inventory concerns. Contact Pfizer at 800-666-7248 or the Poison Help Line at 800-222-1222 for assistance in locating antivenin. If licensed antivenin cannot be secured, an investigational imported antivenin may be available under an Investigational New Drug (IND) protocol with informed consent; for more information contact the Poison Help Line at 800-222-1222 or the FDA at 800-835-4709 (business hours) or 301-796-8240 (nonbusiness hours).
B. Braun Medical Recalls Cefepime
B. Braun Medical is voluntarily recalling 1 lot (H3A744, expiration date January 2015) of cefepime for injection and dextrose injection 1 g due to visible organic particulate matter in a reserve sample unit. Although B. Braun has not received any reports of adverse events related to this lot to date, the company is notifying its distributors and customers by written, return-receipt letters and is arranging for return of all recalled product. The affected lot was distributed nationwide between February 4, 2013, and March 1, 2013.
Patients should report any issues related the use of this product to their health care provider and to B. Braun at 1-800-854-6851. Distributors and customers should discontinue use immediately and contact B. Braun’s Customer Support Department at 1-800-227-2862, Monday through Friday, 8 AM to 7 PM EST for return and replacement instructions.
Nephron Recalls Albuterol Sulfate Inhalation Solution 0.083%
Nephron Pharmaceuticals is voluntarily recalling 10 lots (A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A, A3A40A, A3A41A, and A3A42A) of albuterol sulfate inhalation solution 0.083% at the retail level due to results from its internal monitoring processes. Although all affected lots had passed the company’s quality specifications at the time of manufacturing, the recall was initiated as a precautionary measure in accordance with FDA published guidance on aseptic processing simulation. For more information, consumers should contact Nephron at 1-800-443-4314, ext. 2292 or at email@example.com.
FDA Approves Otrexup
The FDA has approved Antares Pharma’s Otrexup (methotrexate) injection for once weekly subcutaneous self-administration with an easy-to-use, single-dose, disposable autoinjector. Otrexup is indicated in the management of selected adults with severe, active rheumatoid arthritis (American College of Rheumatology criteria), or children with active polyarticular juvenile idiopathic arthritis, who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose nonsteroidal anti-inflammatory drugs. The FDA also approved adult use of Otrexup for symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy.
FDA Approves Nonprescription Nasacort Allergy 24HR
The FDA has approved Sanofi’s Nasacort Allergy 24HR (triamcinolone acetonide) nasal spray as a once-daily nonprescription treatment for seasonal and perennial allergic rhinitis in adults and children 2 years and older. Nasacort Allergy 24HR is the first glucocorticoid to be made available without a prescription and will be marketed by Chattem.
Nasacort Allergy 24HR was initially approved as a prescription-only product (called Nasacort AQ) in the United States in 1996.
Chattem anticipates that Nasacort Allergy 24HR will be available in Spring 2014.
FDA Investigating Iclusig After Reports of Serious Blood Clots
The FDA is investigating an increasing frequency of reports of serious and life-threatening thrombosis and severe vascular stenosis in patients taking the leukemia chemotherapy drug Iclusig (ponatinib).
At the time of Iclusig’s approval in December 2012, the prescribing information contained information about the risks of thrombosis in the Boxed Warning and Warnings and Precautions sections. In clinical trials conducted before approval, serious arterial thrombosis and venous thrombosis occurred in 8% and 3%, respectively, of Iclusig-treated patients. In the most recent clinical trial, at least 20% of all participants developed thrombosis or vascular stenosis.
Iclusig is used to treat adults with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia that is resistant or intolerant to prior tyrosine kinase inhibitor therapy.
Health care providers should consider whether the treatment benefits are likely to exceed the risks. Patients should seek immediate medical attention if they experience symptoms suggesting myocardial infarction.
Acute Hepatitis Cases Linked to OxyElite Pro
The FDA, the Centers for Disease Control and Prevention (CDC), and the Hawaii State Department of Health are investigating reports of acute nonviral hepatitis. The Hawaii State Department of Health has found that 24 of the 29 reported cases share a common link to the use of OxyElite Pro, a dietary weight-loss supplement distributed by USPlabs in Dallas, Texas, and sold nationwide via the Internet and retail stores.
In the 29 reported cases, 11 people have been hospitalized with acute hepatitis, 2 have received liver transplants, and 1 has died. The CDC is also looking at other incidences of liver injury nationwide that may be related. Symptoms can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes, and jaundice.
The FDA is advising consumers to stop using any dietary supplement product labeled as OxyElite Pro (counterfeit product may exist) while the investigation continues and to contact their health care provider if they believe they have been harmed by using a dietary supplement.
FDA Approves Adempas
The FDA has approved Bayer’s Adempas (riociguat) tablets for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) as well as for the treatment of adults with pulmonary arterial hypertension (PAH). Adempas is a stimulator of soluble guanylate cyclase, representing a new class of drugs. Adempas labeling contains a Boxed Warning regarding the risk of embryo-fetal toxicity in pregnant women will be dispensed with a patient Medication Guide.
Lidocaine HCl 1% Recall
Hospira is voluntarily recalling 1 lot (25-090-DK [lot number may be followed by 01 or 02], NDC 0409-4276-01) of lidocaine HCl 1% injection, USP, 10 mg/mL, 20 mL multiple-dose fliptop vials, due to a confirmed customer report of visible dark red/black particulate in the primary container identified as oxidized stainless steel. If undetected, a particle could block drug administration to the patient, causing a delay in therapy.
Existing inventory of the affected lot should be quarantined immediately and distribution discontinued. Customers should call Stericycle at 1-866-364-8812, Monday through Friday, 8 AM to 5 PM EST to arrange for product return. Replacement product from other lots is available.
FDA Approves Generic Zymaxid
The FDA has approved Lupin’s gatifloxacin ophthalmic solution 0.5%, the generic version of Zymaxid ophthalmic solution, indicated for the treatment of bacterial conjunctivitis.
FDA Approves Duavee for Menopausal Symptoms
The FDA has approved Pfizer’s Duavee (conjugated estrogens/bazedoxifene) once-daily tablets for the treatment of moderate to severe hot flashes associated with menopause and for the prevention of osteoporosis after menopause in postmenopausal women who still have a uterus. Duavee, the first FDA-approved medication combining estrogen with an estrogen agonist/antagonist, should be available in the first quarter of 2014.
FDA Approves Clinolipid for Intravenous Nutrition
The FDA has approved Baxter Healthcare’s Clinolipid (lipid injectable emulsion) for parenteral nutrition in adult patients who are unable to eat or drink and need a source of calories and essential fatty acids. Clinolipid should be used with caution in patients with preexisting liver disease or liver insufficiency, and should not be used in patients with a known hypersensitivity to egg or soybean proteins or in patients with hyperlipidemia. Clinolipid was granted a priority review to help alleviate a drug shortage.
FDA Approves Generic Zemplar
The FDA has approved Teva Pharmaceuticals’ paricalcitol capsules, the generic version of Zemplar. Paricalcitol capsules are an active form of vitamin D used to prevent and treat secondary hyperparathyroidism in patients with chronic kidney disease (CKD) stages 3 and 4, as well as to treat and prevent secondary hyperparathyroidism in patients with CKD stage 5 who are on hemodialysis or peritoneal dialysis.
Metoclopramide and Ondansetron Recall
Hospira has initiated a voluntary recall of 1 lot (28-104-DK , NDC 0409-3414-01, expiration date October 1, 2014) of metoclopramide injection 10 mg/2 mL (5 mg/mL) and 2 lots (29-484-DK and 29-510-DK, NDC 0409-4755-03, expiration date May 1, 2015) of ondansetron injection 4 mg/2 mL (2 mg/mL) after glass strands were identified as being affixed to the inside of vial walls. Glass particulates could potentially dislodge into the solution, although there have been no reports of any adverse events to date. The affected lots were distributed nationwide between June 2013 and September 2013 to wholesalers/distributors, hospitals, and pharmacies.
Existing inventory of the affected lots should be quarantined immediately and distribution discontinued. Customers should call Stericycle at 1-877-497-3125, Monday through Friday, 8 AM to 5 PM EST to arrange for product return.
FDA Approves Hizentra Boxed Warning, Expands Dosing
The FDA has approved a new Boxed Warning for CSL Behring’s Hizentra (immune globulin subcutaneous [human]) 20% liquid alerting health care providers that thrombosis may occur. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, use of indwelling central vascular catheters, and hyperviscosity, as well as cardiovascular risk factors. Thrombosis may also occur in the absence of known risk factors.
In addition to the once-weekly dosing that was previously approved, the FDA has expanded the administration options to include biweekly dosing for patients diagnosed with primary immunodeficiency.
Hizentra is indicated for replacement therapy for primary humoral immunodeficiency in adults and pediatric patients 2 years and older. This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
FDA Approves Perjeta for Breast Cancer
The FDA has granted accelerated approval of Genentech’s Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer before surgery (neoadjuvant setting). Perjeta is the first FDA-approved drug for the neoadjuvant treatment of breast cancer. It is indicated for use in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.
Perjeta was approved in 2012 for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2–positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Perjeta carries a Boxed Warning regarding cardiomyopathy and embryo-fetal toxicity.
FDA Approves Brintellix Antidepressant
The FDA has approved Takeda Pharmaceuticals’ and Lundbeck’s Brintellix (vortioxetine) 5, 10, 15, and 20 mg tablets for the treatment of adults with major depressive disorder.
Brintellix and other antidepressant drugs have a Boxed Warning and a Medication Guide alerting patients and health care providers that antidepressants can increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment. Studies show adults older than 24 years do not appear to have an increased risk of suicidal thoughts and behavior, while adults 65 and older appear to have a reduced risk. Patients starting antidepressant therapy should be closely monitored for worsening of their depression and the emergence of suicidal thoughts and behavior.
Expanded Indication for Cimzia
The FDA has approved UCB Pharmaceuticals’ Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis. Cimzia is also approved for reducing signs and symptoms of Crohn disease and maintaining clinical response in adults with moderately to severely active disease who have had an inadequate response to conventional therapy, as well as for the treatment of moderately to severely active rheumatoid arthritis in adults.
Expanded Indication for Hecoria
The FDA has approved Novartis’ Hecoria (tacrolimus) capsules for the prophylaxis of organ rejection in patients receiving heart transplants. Hecoria is also approved for the prophylaxis of organ rejection in patients receiving kidney and liver transplants.
FDA Issues Safety Concern for Budesonide
The FDA has alerted patients and health care providers that budesonide solution, used for nasal irrigation, from The Compounding Shop of St. Petersburg, FL, may be contaminated and should not be used or administered to patients. The FDA observed a 1,000 mL bottle of budesonide solution that contained visible white floating material identified as a fungus. There is concern that contamination may be present in other budesonide solution products from The Compounding Shop that may currently be on the market.
The FDA is alerting health care providers to immediately quarantine any budesonide solution products from The Compounding Shop, and not administer it to patients.
In May 2013 after preliminary investigation findings, the FDA advised the firm to remove all sterile products from the market. The Compounding Shop informed the FDA that it was recalling sterile products and was in the process of notifying customers.
FDA Warns of Increased Risk of Death with Tygacil, Approves New Boxed Warning
The U.S. Food and Drug Administration (FDA) is warning that an additional analysis shows an increased risk of death when Pfizer’s Tygacil (tigecycline) injection is used for FDA-approved uses as well as nonapproved uses. A new Boxed Warning is to be added to the label along with updated Warnings and Precautions and Adverse Reactions sections. These changes are based on an additional analysis that was conducted for FDA-approved uses after issuing a Drug Safety Communication (DSC) in September 2010.
In the 2010 DSC, the FDA informed the public that a meta-analysis of 13 phase 3 and 4 trials showed a higher risk of death among patients receiving Tygacil compared with other antibacterial drugs: 4% (150/3,788) versus 3% (110/3,646), respectively. The adjusted risk difference for death was 0.6%, with corresponding 95% confidence interval (CI) (0.1 to 1.2). The increased risk was greatest in patients treated with Tygacil for ventilator-associated pneumonia, a use for which the FDA has not approved the drug.
Since issuing the 2010 DSC, the FDA analyzed data from 10 clinical trials conducted only for FDA-approved uses, including trials conducted after the drug was approved. This analysis showed a higher risk of death among patients receiving Tygacil compared with other antibacterial drugs: 2.5% (66/2,640) versus 1.8% (48/2,628), respectively. The adjusted risk difference for death was 0.6%, with corresponding 95% CI (0% to 1.2%). In general, the deaths resulted from worsening infections, complications of infection, or other underlying medical conditions.
Healthcare providers should reserve Tygacil for use in situations when alternative treatments are not suitable. Tygacil is FDA-approved to treat complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia.
W.S. Badger Sunscreen Recall
W.S. Badger is recalling all lots of its SPF 30 Baby Sunscreen Lotion 4 oz. and 1 lot (#3164A) of its SPF 30 Kids Sunscreen Lotion 4 oz. due to microbial contamination with Pseudomonas aeruginosa, Candida parapsilosis, and Acremonium fungi.
Consumers should not use these products and may return them to the original point of purchase for a full refund or contact Badger directly at 1-800-603-6100 or firstname.lastname@example.org, Monday through Friday, 8:30 AM to 4:30 PM EST.
Expanded Indication for Suprane
The FDA has approved Baxter’s Suprane (desflurane) liquid for inhalation for maintenance of anesthesia for inpatient and outpatient surgery in intubated pediatric patients. Suprane is also approved for induction and/or maintenance of anesthesia for inpatient and outpatient surgery in adults.
Safety Labeling Changes for Arzerra and Rituxan
The FDA has approved prescribing information changes to GlaxoSmithKline’s Arzerra (ofatumumab) and Genentech’s Rituxan (rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection. The revised labels will also include additional recommendations for screening, monitoring, and managing patients on these drugs to decrease this risk. This is a new Boxed Warning for ofatumumab. The Boxed Warning for rituximab already describes the risk of fatal infusion reactions, tumor lysis syndrome, severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML). Ofatumumab and rituximab are monoclonal antibodies approved for chronic lymphocytic leukemia. Rituxan is also approved for granulomatosis with polyangiitis (Wegener granulomatosis), microscopic polyangiitis, non-Hodgkin lymphoma, and rheumatoid arthritis.
New Indication for Stelara
The FDA has approved Janssen Biotech’s Stelara (ustekinumab) alone or in combination with methotrexate for the treatment of active psoriatic arthritis in adults 18 years or older. Stelara is also indicated for treatment of plaque psoriasis in adults 18 years and older who are candidates for phototherapy or systemic therapy. Stelara is dispensed with a patient Medication Guide.
FDA Approves Generic Vidaza
The FDA has approved Dr. Reddy’s Laboratories’ azacitidine for injection 100 mg/vial, the generic version of Vidaza, for the treatment of patients with the following French-American-British myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia. The company plans to launch the product as soon as possible.
Duragesic Patch Safety Alert
The FDA is requiring Janssen to make color changes in long-lasting ink to the writing on Duragesic (fentanyl) transdermal patches so that the name and strength can be seen more easily. As the FDA continues to learn of serious harm and deaths from accidental exposure to fentanyl patches, patients and health care providers are reminded that the patches are dangerous even after use because they still contain high amounts of strong narcotic pain medicine. The change is intended to enable patients and caregivers to more easily find patches on patients’ bodies and locate patches that have fallen off. The manufacturers of generic fentanyl patches are being requested to make similar changes. Read a previous story here.
Expanded Indication for Botox Cosmetic
The FDA has approved Allergan Pharmaceuticals’ Botox Cosmetic (onabotulinumtoxinA) for temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity in adults. Botox Cosmetic is also approved for temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugators and/or procerus muscle activity in adults.
FDA Approves Generic Xeloda
The FDA has approved Teva Pharmaceuticals’ ANDA for capecitabine 150 and 500 mg tablets, the generic version of Xeloda, indicated for the treatment of metastatic colorectal cancer and metastatic breast cancer.
Bupivacaine 0.25% and 0.75% Recalled
Hospira issued a voluntary recall of 1 lot (18-136-DK, NDC 0409-1159-02; expiration date June 1, 2014) of bupivacaine HCl 0.25% injection, USP (2.5 mg/mL), 30 mL single-dose vials on July 12, 2013. The lot was distributed August 2012 through September 2012. An expanded recall was issued on August 29, 2013, for 1 lot (23-338-DK, NDC 0409-1165-02; expiration date November 1, 2014) of bupivacaine HCl 0.75% injection, USP (7.5 mg/mL), 30 mL single-dose vials. The lot was distributed January 2013 through May 2013. Both recalls are due to confirmed customer reports of particulate floating and/or embedded in the glass vial. The particulate was identified as stainless steel ranging in size from 542 microns to 1,700 microns in the bupivacaine 0.25% injection, and as iron oxide with an average size of 2,000 microns in the bupivacaine 0.75% injection.
Any affected product should be immediately quarantined. Product returns can be arranged by contacting Stericycle at 1-866-240-5364 (lot 18-136-DK) and 1-888-627-2279 (lot 23-338-DK), Monday through Friday, 8 AM to 5 PM EST.
Creafuse Powder Grape and Creafuse Powder Fruit Punch Supplement Recall
Ge Pharma is recalling Creafuse Powder Grape (lot GE4568) and Creafuse Powder Fruit Punch (lot GE4570) due to the presence of 1,3 dimethylamylamine (DMAA), which can elevate blood pressure and lead to cardiovascular problems. Although DMAA is commonly used as a stimulant, preworkout, and weight loss ingredient in dietary supplement products, the FDA has warned that it is not a dietary ingredient and is not Dietary Supplement Health and Education Act (DSHEA) compliant.
Consumers should immediately discontinue use of these products and contact their health care professional if they have experienced any adverse effects. GE Pharma can be contacted at email@example.com or 1-203-675-1057, Monday through Friday, 11 AM to 5 PM EST, for further instructions for product disposal or return, refunds, credits, exchanges, or any other questions.
Utopic Cream Approved
The FDA has approved Artesa Labs’ Utopic (urea 41%) cream for the treatment of hyperkeratotic conditions such as dry, rough skin; xerosis; ichthyosis; skin cracks and fissures; dermatitis; eczema; psoriasis; keratoses; and calluses.
SelRX Shampoo Approved
The FDA has approved Artesa Labs’ SelRX Shampoo (selenium sulfide 2.3%) for the treatment of seborrheic dermatitis of the scalp, dandruff, and tinea versicolor. It may also be used to treat dry scalp.
Risperdal Consta Recall
Johnson & Johnson is voluntarily recalling 1 lot of Janssen Pharmaceuticals’ Risperdal Consta (risperidone microspheres) intramuscular suspension after discovering mold during a routine testing process. Risperdal Consta is indicated as monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder, as well as for the treatment of schizophrenia.
Astepro Indication Expanded
The FDA has approved Meda Pharmaceuticals’ Astepro (azelastine hydrochloride) for the treatment of symptoms of seasonal and perennial allergic rhinitis in patients 6 years and older. Astepro was previously approved for the treatment of perennial and seasonal rhinitis in patients 12 years and older.
Leiter’s Compounding Pharmacy Recall
Leiter’s Compounding Pharmacy is voluntarily recalling 3 lots of sterile products (bevacizumab lots 08052013@1 and 08052013@4, expiration date November 3, 2013, and lidocaine/phenylephrine lot 07302013@6, expiration date October 28, 2013) due to the FDA’s sterility assurance concerns with their independent testing laboratory. The affected products were dispensed to health care providers between August 5, 2013 and September 2, 2013 throughout the US.
Leiter’s Compounding Pharmacy is notifying prescribing health care providers by mail, telephone, and/or email, and is arranging for return of all recalled products, which should not be used. Customers with questions can contact Leiter’s Compounding Pharmacy at 1-800-292-6772, Monday through Friday, 8 AM to 5 PM PST.
Testosterone Cypionate Recall
Park Compounding is voluntarily recalling 1 lot of sterile medication testosterone cypionate (sesame oil) 200 mg/mL (lot 05072013@1, expiration date November 3, 2013) for injection in 10 mL amber vials to the consumer level due to concerns that results obtained from the laboratory were not reliable. The prescription preparations were sold during May and June of 2013 in California and Indiana directly to customers and to health care providers’ offices by prescription.
Customers who have the affected product should stop using it and contact Park Compounding to arrange for return of unused product. Customers with questions can contact Park Compounding at 1-949-551-7195, Monday through Friday, 9 AM to 5 PM PST or firstname.lastname@example.org. Customers should contact their health care provider if they have experienced any problems that may be related to taking or using the affected medication.
Safety Labeling Changes for Extended-release and Long-acting Opioid Analgesics – September 2013
The U.S. Food and Drug Administration has announced class-wide safety labeling changes and new postmarket study requirements for all extended-release (ER) and long-acting opioid analgesics to address the misuse, abuse, addiction, overdose, and death associated with these drugs.
Labeling changes will include important new language to help health care providers tailor their prescribing decisions based on a patient’s needs. The updated indication states that these drugs are for the management of severe pain requiring daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Because of the risks of addiction, abuse, and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options (eg, nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; ER and long-acting opioid analgesics are not indicated for as-needed pain relief.
The FDA is also requiring a new boxed warning cautioning that chronic maternal use of ER and long-acting opioid analgesics during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening and require management by neonatology experts. Symptoms associated with NOWS include tachypnea, trembling, poor feeding, and excessive or high-pitched crying.
Modifications will also be made to the Risk Evaluation and Mitigation Strategy (REMS) to reflect the updated information. Originally approved in 2012, the REMS requires that companies make available educational programs on how to safely prescribe ER and long-acting opioid analgesics and Medication Guides and patient counseling documents.
Further information may be found at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm367726.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.
Avella Specialty Pharmacy Recall
Avella Specialty Pharmacy is voluntarily recalling 2 compounded sterile medications, bevacizumab 1.25 mg per 0.05 mL PF (lot 12-20130508@179, expiration November 3, 2013) and vancomycin PF (BSS) 1% (lot 12-20130508@181, expiration October 4, 2013). The recall is a result of concerns of sterility assurance with the specialty pharmacy’s independent testing laboratory, Front Range Laboratories.
The FDA raised concerns that test results obtained from Front Range Labs may not be reliable after an investigation revealed methods used to assess sterility and other qualities (eg, strength, stability) that may have resulted in Avella receiving inaccurate laboratory test results on the specified lots. The recalled products were dispensed directly to health care providers nationwide.
Avella Specialty Pharmacy is notifying customers of the voluntary recall by phone and mail. Customers should immediately discontinue use and return the unused portion to Avella. Patients should contact their health care provider if they have experienced any problems. Questions can be directed to Avella at 1-877-738-0797, Monday through Friday, 6 AM to 6 PM PST or QA@avella.com.
Carboxymethylcellulose Sodium Recall
Altaire Pharmaceuticals is voluntarily recalling 9 lots (http://www.fda.gov/Safety/Recalls/ucm367559.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery) of carboxymethylcellulose sodium 0.5% ophthalmic solution 30 mL to the consumer level. Concerns regarding the effectiveness of the preservative after use and handling of the product by consumers have prompted the recall because of mold found in the bottles after use.
All lots of product were sterile at the time of release, and the preservative was effective when challenged against the USP Preservative Effectiveness Test. Altaire has confirmed the production facility is not the source of any reported contaminants.
Altaire is notifying its customers of the recall by phone and letters for further notification to their retail stores. Consumers who have the product should stop use immediately and return it to the place of purchase.
Motrin Infants Drops Recall
Johnson & Johnson’s McNeil Consumer Healthcare has issued a voluntary recall of 3 lots (DCB3T01, DDB4R01, DDB4S01) of concentrated Motrin Infants’ Drops Original Berry Flavor 0.5 ounce bottles because they may contain tiny plastic particles. Motrin Infants’ Drops (ibuprofen) is indicated for the temporary reduction of fever and relief of minor aches and pains due to colds, flu, sore throat, and toothaches in children 2 years and younger. Consumers should stop using the affected product and call the company for a refund at 1-877-414-7709.
FDA Approves Generic Hepsera Tablets
The FDA has approved Sigmapharm Laboratories’ ANDA for adefovir dipivoxil tablets 10 mg, the generic version of Hepsera, indicated for the treatment of chronic hepatitis B virus in patients 12 years and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Abraxane Approved for Late-Stage Pancreatic Cancer
The FDA has approved Celgene’s Abraxane (paclitaxel protein-bound particles) injection solution for the treatment of advanced pancreatic cancer. Abraxane is intended to be used in combination with gemcitabine in patients with metastatic pancreatic cancer. Abraxane is also indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy, as well as in combination with carboplatin as first-line treatment of locally advanced or metastatic non–small cell lung cancer in patients who are not candidates for curative surgery or radiation therapy.
Medaus Pharmacy Recall
Medaus Pharmacy is voluntarily recalling certain sterile compounded consumer products (http://www.fda.gov/Safety/Recalls/ucm367353.htm) due to the company’s inability to confirm that quality control testing performed on these specific lots by an independent, third-party laboratory was conducted in a manner consistent with standards. The products were dispensed between March 12 and July 22, 2013, throughout the US.
Medaus is notifying its customers by telephone and email, and is arranging for return of affected products. Health care facilities and customers should stop using the products and call Medaus at 1-800-526-9183, Monday through Friday, 9 AM to 5 PM CDT, for instructions on product return.
Aminosyn II 10% Recall
Hospira has initiated a voluntary nationwide user-level recall of 1 lot (26-138-JT, NDC 0409-4164-03, expiration date August 1, 2014) of Aminosyn II 10%, sulfite-free, 500 mL, due to 1 report of a human hair in the injection port and in contact with the product. The affected lot was distributed nationwide between March 2013 and August 2013 to wholesalers/distributors, hospitals, and pharmacies.
Existing inventory of the affected lot should be quarantined immediately and distribution discontinued. Customers should call Stericycle at 1-866-737-4701, Monday through Friday, 8 AM to 5 PM EST to arrange for product return.
Cubist Pharmaceuticals has notified customers of the voluntary recall of 4 lots (950453F, 090203F, 201703F, 201653F, shipped May 2011 to March 2013) of Cubicin (daptomycin) injection due to the presence of particulate matter.
Anyone with an existing inventory of the product lots listed in the firm's press release (http://www.fda.gov/Safety/Recalls/ucm366753.htm) should quarantine them and discontinue distribution. Customers should call Cubist at 1-855-534-8309, Monday through Friday, 9 AM to 7 PM EST to arrange for return and replacement of affected lots.
Health care providers and pharmacists with questions regarding this recall may contact Cubist Medical Information at 1-877-282-4786, Monday through Friday, 8 AM to 5:30 PM EST.
Progressive Multifocal Leukoencephalopathy Warning with Gilenya
The U.S. Food and Drug Administration (FDA) is informing the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed progressive multifocal leukoencephalopathy (PML) after taking Novartis’ Gilenya (fingolimod). This is the first reported case of PML following the administration of Gilenya to a patient who had not previously received Tysabri (natalizumab, an MS drug associated with a higher risk of PML.
The patient received Gilenya for nearly 8 months before being diagnosed with PML. The patient had previously been treated with interferon beta-1a and azathioprine for 1 month, but these medications were discontinued when Gilenya was initiated. The patient also received multiple courses of intravenous corticosteroids for several months before and during Gilenya treatment. The PML diagnosis was made based on clinical symptoms and the detection of JC viral DNA in the cerebrospinal fluid and Gilenya treatment was stopped.
Patients should not stop taking Gilenya without first discussing any questions or concerns with their health care providers. The FDA is investigating the PML case, and working with Novartis to obtain and review all available information.
For additional information, please refer to http://www.fda.gov/Drugs/DrugSafety/ucm366529.htm.
282 MEP Market Withdrawal, Health Canada Issues Notice--August 2013
Pendopharm, in collaboration with Health Canada, has issued notice of the market withdrawal of 282 MEP (acetylsalicylic acid 350 mg, codeine phosphate 15 mg, meprobamate 200 mg, caffeine 15 mg). On July 30, 2013, Pendopharm discontinued the sale of 282 MEP. Following the discontinuation of 282 MEP, no medications containing meprobamate will be available in Canada. Effective October 28, 2013, the drug identification number for 282 MEP will be cancelled.
Health Canada has evaluated information on the risk of overdose/abuse/misuse in patients treated with 282 MEP, a meprobamate-containing medicine indicated for the relief of pain accompanied by muscle spasm and anxiety. Meprobamate has a narrow therapeutic index and may cause serious adverse reactions, including overdose, loss of consciousness, abuse, pharmacodependence, and withdrawal symptoms, even under normal conditions of use. Other medications (eg, muscle relaxants, anxiolytics, antidepressants) have largely displaced the use of meprobamate in Canada and in other countries. Taking this data into account, Health Canada has concluded that the risks of 282 MEP outweigh the benefits under normal conditions of use. Patients taking 282 MEP should be switched to an alternative treatment.
Valchlor Gel Approved
The FDA has approved Ceptaris Therapeutics’ Valchlor (mechlorethamine) gel for once-daily topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. Currently the only FDA-approved topical formulation of mechlorethamine, Valchlor will be available in the fourth quarter of 2013.
Expanded Boxed Warning for Letairis
The FDA has expanded the Boxed Warning for Gilead Sciences’ Letairis (ambrisentan) to include the following statements: Females of reproductive potential must use acceptable methods of contraception during treatment with Letairis and for 1 month after treatment. Obtain monthly pregnancy tests during treatment and 1 month after therapy discontinuation.
The Boxed Warning already stated that the drug is contraindicated during pregnancy and should not be administered to pregnant women as it may cause fetal harm.
Wellness Pharmacy Recalls Certain Sterile Products
Wellness Pharmacy is voluntarily recalling certain sterile products due to laboratory results indicating microbial contamination. FDA investigators observed that methods used to assess sterility may have resulted in pharmacies receiving inaccurate sterility test results.
- Dexpanthenol 250 mg/mL (lot 130605@52, expiration date December 2, 2013)
- Magnesium sulfate 50% (lot 130613@38, expiration date December 10, 2013)
- Methylcobalamin 1 mg/mL (lot 130612@49, expiration date December 9, 2013 and October 19, 2013)
- Sodium phenylbutyrate 200 mg/mL SDV PF (lot 130621@28, expiration date October 19, 2013)
- R.L. glutathione 100 mg/mL SUV PF (lot 130710@27, expiration date January 6, 2014)
- Ascorbic acid (cassava) 500 mg/mL PF SUV (lot 130711@13, expiration date January 7, 2014)
The lots were distributed to individual patients and to physician offices nationwide. Customers should contact their health care provider if they have experienced any problems that may be related to taking these medications.
Customers with questions regarding this recall or for product return information should contact Wellness Pharmacy at 205-879-6551 or 800-227-2627, Monday through Friday, 9 AM to 4 PM CST.
JCB Laboratories Recalls Sterile Drug Products
JCB Laboratories is recalling 6 lots of sterile drug products to the user level due to concerns of sterility assurance following a recent inspection by the FDA.
The following compounded products are subject to the recall:
- Sodium thiosulfate, 25% 250 mg/mL – (lots 130701@9, expiration date December 28, 2013; 130709@6, expiration January 5, 2014; and 130717@2, expiration January 13, 2014)
- Sodium citrate, 4% solution for injection, 30 mL multiple-dose vial (lot 130710@4, expiration January 6, 2014)
- Sodium citrate, 4% with gentamicin 320 mcg/mL solution for injection, 30 mL multiple-dose vial (lot 130620@2, expiration December 17, 2013)
- Acetylcysteine, 20% solution for inhalation, 4 mL single-dose vials (lot 130627@5, expiration August 26, 2013)
The recalled products were distributed to outpatient dialysis clinic in multiple states from July 8, 2013 through August 20, 2013. Customers should contact their health care provider if they have experienced any problems that may be related to taking or using these products.
For information regarding this recall or for product return information, call JCB Laboratories at 316-773-0405, Monday through Friday, 8 AM to 5 PM CST. JCB Laboratories is notifying customers by phone, email, fax, and mail.
Park Pharmacy Recalls Methylcobalamin and Multitrace-5 Injections
Park Pharmacy & Compounding Center of Irvine, CA, is voluntarily recalling methylcobalamin 5 mg/mL 30mL amber vials (lot 06132013@1, expiration date December 12, 2013) and Multitrace-5 concentrate 10 mL amber vials (lot 05212013@20, expiration date November 11, 2013) for injection to the consumer level. FDA investigators observed that methods used to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. The lots were sold directly to customers (pick up and by mail) and to health care providers by prescription (pick up and by mail) during June and July 2013, in California, Florida, New Mexico, and Indiana. Customers should contact their health care provider if they have experienced any problems that may be related to taking or using these preparations.
Customers with questions regarding this recall can contact Park Pharmacy & Compounding Center at 949-551-7195 or email@example.com, Monday through Friday, 9 AM to 5 PM PST. Park Pharmacy & Compounding Center is notifying its customers by phone and mail, and is arranging for return of all recalled products. Customers with a recalled product should stop using it and contact Park to arrange for return of unused product.
FDA Approves Mirvaso for Erythema of Rosacea
The FDA has approved Galderma Laboratories’ Mirvaso (brimonidine), a once-daily topical gel 0.33% for the treatment of persistent (nontransient) erythema of rosacea in adults 18 years and older. Galderma expects Mirvaso to be available in pharmacies September 2013.
FDA Approves Trokendi XR
The FDA has approved Supernus Pharmaceuticals’ Trokendi XR (topiramate) extended-release capsules for initial monotherapy for the treatment of seizures in patients 10 years and older with partial onset or primary generalized tonic-clonic seizures; as adjunctive therapy in patients 6 years and older with partial onset or primary generalized tonic-clonic seizures; and as adjunctive therapy in patients 6 years and older with seizures associated with Lennox-Gastaut syndrome. Trokendi XR will be available in the next few weeks.
Risks of Malignancy Progression and Drug Rash With Eosinophilia and Systemic Symptoms, Health Canada Issues Notice-August 2013
Hoffmann-La Roche Limited, in collaboration with Health Canada, has issued notice to health care providers regarding the risk of malignancy progression as well as the risk of drug rash with eosinophilia and systemic symptoms (DRESS) syndrome associated with vemurafenib (Zelboraf).
Based on its mechanism of action, vemurafenib may cause progression of cancers associated with rat sarcoma viral oncogene (RAS) mutations. Accelerated growth of a preexisting neuroblastoma (RAS) mutated chronic myelomonocytic leukemia has been recently reported in a patient shortly after initiating vemurafenib therapy, suggesting that vemurafenib can cause paradoxical activation of extracellular signal-regulated kinase signaling in the RAS-mutant leukemic cell population, which could lead to leukemic cell proliferation. Vemurafenib should be used with caution in patients with previous or concurrent cancers associated with RAS mutations.
Cases of DRESS syndrome have also been reported, usually within 7 to 25 days. Vemurafenib should be permanently discontinued in patients who develop DRESS syndrome. The manufacturer is working with Health Canada to update the vemurafenib product monograph with this important safety information.
Further information may be found at:http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/35165a-eng.php
Covidien Recalls Monoject Prefill Flush Syringes
Covidien is recalling certain lots (13A0084N, 13A0094, 13B0364, 13C0504, 13C0514, 13A0084N, and 13D0824N) of Monoject prefill flush syringes due to the risk that a number of the syringes were filled with water but not subjected to the autoclave sterilization process. The products are labeled as either sodium chloride flush or heparin lock flush, and some have the mismatched syringe tip cap, syringe label, filled volume, and wrapper. Customers have been notified by letter of this issue. To return the affected product for credit, call 1-800-962-9888.
FDA Approves FluLaval Quadrivalent
The FDA has approved GlaxoSmithKline’s FluLaval Quadrivalent (influenza virus vaccine) intramuscular injection for active immunization of persons 3 years and older to help prevent disease caused by seasonal influenza virus subtypes A and B.
FDA Approves Esomeprazole Strontium
The FDA has approved esomeprazole strontium delayed-release capsules for adults for the treatment of gastroesophageal reflux disease, including healing of erosive esophagitis, maintenance of healing of erosive esophagitis, and symptomatic gastroesophageal reflux disease; risk reduction of nonsteroidal anti-inflammatory drug–associated gastric ulcer; Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence (in combination with amoxicillin and clarithromycin as triple therapy); and pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
FDA Approves Generic Temodar Capsules
The FDA has approved Teva Pharmaceuticals’ temozolomide 5, 20, 100, 140, 180, and 250 mg capsules, the generic version of Temodar, indicated for the treatment of adults with newly diagnosed glioblastoma multiforme who are concomitantly undergoing radiotherapy and then as maintenance treatment, and for refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
Nexus Recalls Benztropine Mesylate Injection
Nexus Pharmaceuticals is voluntarily recalling at the user level 2 lots (030712, expiration date March 2014; 112911, expiration date November 2013) of benztropine mesylate injection 2 mg per 2 mL (1 mg/mL) in 2 mL single-dose vials due to the potential presence of visible particulate matter in the vials. To return unused products, contact Nexus at 1-888-806-4606. To report adverse events or quality problems, contact Nexus Medical Affairs at 1-877-913-2720 or email firstname.lastname@example.org. Fresenius Kabi USA also recently recalled 4 lots of benztropine mesylate injection (http://online.factsandcomparisons.com/News/NewsArticle.aspx?id=1009561).
Fluoroquinolones and Potential Peripheral Neuropathy Risk
The FDA is requiring that the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy, which can occur at any time during treatment. Symptoms include pain, burning, tingling, numbness, or weakness, a change in sensation to light touch, pain, or temperature, or in the sense of body position.
The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken orally or by injection. Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive). Topical fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.
If a patient develops symptoms of peripheral neuropathy, the drug should be stopped, and the patient switched to a nonfluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk. Fluoroquinolone-associated peripheral neuropathy can last for months to years after the drug is stopped or in some cases may become permanent.
For more information, see the Fluoroquinolones Drug Safety Alert.
FDA Approves Tivicay for HIV-1 Infection
The FDA has approved GlaxoSmithKline’s Tivicay (dolutegravir) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children 12 years and older and weighing at least 40 kg.
Specialty Compounding Recalls Sterile Products
Specialty Compounding of Cedar Park, TX, is voluntarily recalling all lots of unexpired sterile products dispensed since May 9, 2013, including all strengths and dosage forms. The recall was initiated after reports of bacterial infection affecting 15 patients at 2 Texas hospitals whose treatments included intravenous infusions of calcium gluconate from Specialty Compounding. There is a potential association between the infections and the medication at this time.
Recalled products were distributed directly to hospitals and health care offices in Texas and directly to patients in every state except North Carolina.
To return products or request assistance related to this recall, users should contact Specialty Compounding at 1-512-219-0724, Monday through Friday, 10 AM to 5 PM CDT.
Expanded Boxed Warning for Prozac
The FDA has expanded the Boxed Warning for Dista’s Prozac (fluoxetine hydrochloride) to include the following statements: Prozac is not approved for children less than 7 years of age. When using Prozac and olanzapine in combination, also refer to the Boxed Warning section of the package insert.
The Boxed Warning had already stated that antidepressants increased the risk of suicidal thoughts and behavior in short-term studies in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders.
FDA Approves Fetzima for Depression
The FDA has approved Forest Laboratories’ and Pierre Fabre Laboratories’ Fetzima (levomilnacipran), a once-daily serotonin and norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder. The labeling includes a Boxed Warning regarding the risk of suicidal thoughts and behaviors.
Menveo Approved for Use in Infants
The FDA has approved Novartis’ Menveo (meningococcal [groups A, C, Y and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine) for active immunization to prevent meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in patients 2 months to 55 years of age. Menveo was previously approved for use in patients 2 to 55 years of age. See the previous story for more information.
FDA Approves Lo Minastrin Fe to Prevent Pregnancy
The FDA has approved Warner Chilcott’s Lo Minastrin Fe (norethindrone acetate and ethinyl estradiol chewable tablets, ethinyl estradiol tablets, and ferrous fumarate tablets) for oral use for the prevention of pregnancy in women of reproductive age. Lo Minastrin Fe carries a Boxed Warning regarding the increased risk of serious cardiovascular events in women who smoke cigarettes while taking this drug. This risk increases with age, particularly in women older than 35 years, and with the number of cigarettes smoked. Lo Minastrin Fe should not be used by women who are older than 35 years and smoke.
Beacon Hill Medical Pharmacy/Rxtra Solutions Issues Recall
Beacon Hill Medical Pharmacy and the FDA are notifying health care providers and consumers of the recall of all lots of certain sterile products because of a possible lack of sterility.
The list of sterile injectable products under recall, in alphabetical order and organized by drug name and strength, can be found on the FDA’s recall list (http://www.fda.gov/Safety/Recalls/ucm363284.htm). The lot numbers start with code 01012013@1 to 07262013@99.
Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program online, by returning the postage-paid FDA form 3500 by mail (to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or fax (1-800-332-0178).
FDA Approves Injectafer
The FDA has approved American Regent’s Injectafer (ferric carboxymaltose) injection for the treatment of iron deficiency anemia in adults who have an intolerance to oral iron or have had an unsatisfactory response to oral iron, or who have non–dialysis-dependent chronic kidney disease.
FDA Warning of Serious Skin Reactions with Acetaminophen
The FDA is warning that acetaminophen has been associated with a risk of rare but serious and potentially fatal skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. Reddening of the skin, rash, blisters, and detachment of the upper surface of the skin can occur with the use of products that contain acetaminophen. These reactions can occur with first-time use of acetaminophen or at any time while it is being taken. Other drugs used to treat fever and pain/body aches (eg, NSAIDs) also carry the risk of causing serious skin reactions, as described in the Warnings/Precautions section of these drug labels.
The FDA advises that anyone who develops a skin rash or reaction while using acetaminophen or any other pain reliever/fever reducer should stop the drug and seek medical attention immediately. Patients who have experienced a serious skin reaction with acetaminophen should not take the drug again and should discuss the use of alternative pain relievers/fever reducers with their health care provider.
FDA is requiring that a warning be added to the labels of prescription drug products containing acetaminophen to address the risk of serious skin reactions and is also requesting that manufacturers add a warning about serious skin reactions to acetaminophen-containing OTC product labels.
FDA Approves Mefloquine Boxed Warning
The FDA has approved a Boxed Warning for mefloquine hydrochloride to alert health care providers that mefloquine may cause neuropsychiatric adverse reactions that can persist after the drug has been discontinued. Mefloquine should not be prescribed for prophylaxis of malaria in patients with major psychiatric disorders. If psychiatric or neurologic symptoms occur during prophylactic use, mefloquine should be discontinued and an alternative medication used. Mefloquine is indicated for the treatment of mild to moderate acute malaria and for the prophylaxis of malaria infections.
Revised Warnings for Mefloquine
The FDA has strengthened and updated warnings regarding neurologic and psychiatric side effects associated with the antimalarial drug mefloquine hydrochloride. A Boxed Warning has been added to the drug label. The FDA has also revised the patient Medication Guide dispensed with each prescription and wallet card to include this information. Potential neurologic side effects include dizziness, loss of balance, or ringing in the ears. The psychiatric side effects can include feeling anxious, mistrustful, depressed, or having hallucinations. Neurologic side effects can last for months to years after the drug is stopped, or can be permanent.
Nizoral Safety Alert
The FDA is taking several actions related to Nizoral (ketoconazole) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems, and advising that it can lead to harmful drug interactions. Nizoral oral tablets should not be a first-line treatment for any fungal infection. They should be used for the treatment of endemic mycoses only when alternative antifungal therapies are not available or tolerated. A new Medication Guide will address these safety concerns.
Novartis Vaccines has issued a voluntary recall of 1 lot (M12118 [Men A vial Lot # A12118 and Men CWY vial lot # X12118]) of Menveo meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM-197 conjugate vaccine following observation of higher-than-specified levels of residual moisture within the lyophilized Men A component vial. This residual moisture content is not expected to impact product quality, but constitutes a deviation to registered specifications. No action is required for patients previously vaccinated with a dose from the recalled lot. Customers should check their inventory and follow the steps for return outlined in the notification.
Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program online, by returning the postage-paid FDA form 3500 by mail (to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or fax (1-800-332-0178).
FDA Approves Astagraf XL
The FDA has approved Astellas Pharma’s Astagraf XL (tacrolimus) once-daily, extended-release capsules for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil and corticosteroids, with or without basiliximab induction.
Simponi Aria Approved for RA
The FDA has approved Janssen Biotech’s Simponi Aria (golimumab) infusion for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate. Simponi Aria will be dispensed with a patient Medication Guide.
Human Immune Globulins Black Box Warning Change
The FDA is requiring manufacturers to update the current Black Box Warning in the labels of all intravenous human immune globulin products and to add a Black Box Warning to the labels of all subcutaneous and intramuscular human immune globulin products to highlight the risk of thrombosis and provide information on its mitigation. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm355986.htm#summary
New Indications for Latuda
The FDA has approved Sunovion Pharmaceuticals’ Latuda (lurasidone hydrochloride) as monotherapy and as adjunctive therapy with either lithium or valproate for the treatment of patients with major depressive episodes associated with bipolar I disorder. Latuda is also indicated for the treatment of patients with schizophrenia.
FDA Approves Gilotrif and therascreen Test for Lung Cancer
Filter Cathflo Activase
The FDA is reminding health care providers that the final reconstituted solution of Genentech’s Cathflo Activase (alteplase) must be filtered with a 5-micron filter needle upon withdrawal from the container to remove potential rubber stopper particulates found in some vials after reconstitution.
All vials should be inspected after reconstitution and should not be administered if particulate matter is discovered. Contact Genentech at 1-800-334-0290 to return affected vials and to receive replacement vials. To report adverse events or product quality complaints, or to request medical information related to Cathflo Activase, contact Genentech at 1-800-821-8590, Monday through Friday, 5:30 AM to 4 PM PST.
Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program online, by returning the postage-paid FDA form 3500 by mail (to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or fax (1-800-332-0178).
Sandoz has issued a voluntary recall of 1 lot (LF01213A, expiration date February 2014, NDC 00781-4058-15) of Estarylla (norgestimate/ethinyl estradiol) tablets following a report that a placebo tablet was present in a row of active tablets in one pack.
Patients and health care providers can contact Sandoz at 1-800-525-2492, 7 days a week, 24 hours a day.
FDA Approves Zubsolv for Opioid Dependence
The FDA has approved Orexo’s Zubsolv (buprenorphine/naloxone) once-daily, sublingual tablets for the maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support.
Sprue-like Enteropathy With Olmesartan
The FDA is warning that olmesartan medoxomil (Sankyo’s Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy and the agency has approved labeling changes to include this concern. Olmesartan medoxomil is an angiotensin II receptor blocker approved for the treatment of high blood pressure, alone or with other antihypertensive agents. Health care providers should instruct patients to contact them if they develop severe, chronic diarrhea with substantial weight loss while taking an olmesartan-containing product, even if it takes months to years for symptoms to develop.
Recombivax HB Adult Formulation Recall
Merck Sharp & Dohme has initiated a voluntary recall of 1 lot (J001183; distributed between March 12, 2013 and May 2, 2013) of Recombivax HB adult formulation (hepatitis B vaccine [recombinant]) due to the potential for a limited number of cracked vials to be present in this lot. All product from the affected lot should be inventoried and quarantined, but revaccination is not necessary if product from this lot has been administered. Merck has contacted direct customers who have purchased product from the affected lot and provided instructions for return. Distributors and wholesalers will provide instructions to their customers. For additional information, contact the Merck National Service Center at 1-800-672-6372, Monday through Friday, 8 AM to 7 PM EST.
Problems with vaccine products can be reported to Vaccine Adverse Event Reporting System .
Expanded Black Box Warning for Promethazine/Codeine Antitussive Combinations
The FDA has expanded the Black Box Warning for promethazine hydrochloride/codeine phosphate oral solution and promethazine hydrochloride/phenylephrine hydrochloride/codeine phosphate oral solution. The Black Box Warning now includes the following statement: Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism. The Black Box Warning had already stated that the combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients younger than 6 years, and that postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients younger than 2 years.
Benztropine Mesylate Injection Recall
Fresenius Kabi USA is voluntarily recalling 4 lots (030712, 071212, 090512, and 111412) of benztropine mesylate injection 2 mg/2mL (1 mg/mL) in 2 mL single-dose vials due to the potential presence of glass particles in the vials. The company has discontinued distribution of benztropine mesylate while it investigates the cause.
All customers who received the recalled vials are being notified and instructed to return any unused product to Fresenius Kabi USA. Health care providers can find additional information about the recall on the company’s website or by calling 1-866-716-2459, Monday through Friday, 8 AM to 5 PM CST. Questions regarding product availability and ordering can be directed to customer service at 1-888-386-1300, Monday through Friday, 7 AM to 6 PM CST.
Expanded Indication for Exelon Patch
The FDA has approved an expanded indication for Novartis’ Exelon patch (rivastigmine transdermal system) to include the treatment of severe Alzheimer disease. It was previously approved for the treatment of mild to moderate dementia of the Alzheimer type and mild to moderate dementia associated with Parkinson disease.
FDA Approves Nymalize
The FDA has approved Arbor Pharmaceuticals’ Nymalize (nimodipine) oral solution for the improvement of neurological outcome in adult patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms, regardless of their postictus neurological condition. Nimodipine is also available as a liquid-filled gel capsule.
FDA Approves Brisdelle for Hot Flashes
The FDA has approved Noven Therapeutics’ Brisdelle (paroxetine) capsules for the treatment of moderate to severe hot flashes associated with menopause. Brisdelle is currently the only nonhormonal treatment for hot flashes approved by the FDA. Like other SSRIs, Brisdelle labeling contains a Black Box Warning regarding increased risk of suicide. The drug will be dispensed with a Medication Guide.
FDA Approves Rixubis
The FDA has approved Baxter Healthcare’s Rixubis (coagulation factor IX recombinant) for the control and prevention of bleeding episodes, perioperative management, and routine use to prevent or reduce the frequency of bleeding episodes in patients 16 years and older with hemophilia B.
Hydroxyethyl Starch Solutions Receive Black Box Warning
The FDA has added a Black Box Warning to the labeling for hydroxyethyl starch (HES) solutions after recent data indicated an increased risk of mortality and renal injury requiring renal replacement therapy in critically ill adult patients, including patients with sepsis and those admitted to the intensive care unit (ICU); and excess bleeding particularly in patients undergoing open heart surgery in association with cardiopulmonary bypass.
HES solutions are indicated for the treatment of hypovolemia when plasma volume expansion is desired. Voluven (Hospira) is also indicated for the prophylaxis of hypovolemia when plasma volume expansion is desired. Hespan (B. Braun) is also indicated as an adjunct in leukapheresis to improve harvesting and increase yield of granulocytes by centrifugal means.
FDA Recommendations for Health Professionals:
- Do not use HES solutions in critically ill adult patients including those with sepsis, and those admitted to the ICU.
- Avoid use in patients with preexisting renal dysfunction.
- Discontinue use of HES at the first sign of renal injury.
- Need for renal replacement therapy has been reported up to 90 days after HES administration. Continue to monitor renal function for at least 90 days in all patients.
- Avoid use in patients undergoing open heart surgery in association with cardiopulmonary bypass due to excess bleeding.
- Discontinue use of HES at the first sign of coagulopathy.
New Indication for Vibativ
The FDA has approved Astellas Pharma’s Vibativ (telavancin) for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus. Vibativ should be used for the treatment of HABP/VABP only when alternative treatments are not suitable. Vibativ is approved only to treat S. aureus, not other bacteria that cause pneumonia. A warning concerning the possibility of new or worsening renal problems associated with the use of Vibativ has been added to the drug’s Black Box Warning. Vibativ is also indicated for the treatment of complicated skin and skin structure infections caused by S. aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), or Enterococcus faecalis (vancomycin-susceptible isolates only).
Mycamine Approved for Pediatric Use
The FDA has approved Astellas Pharma’s Mycamine (micafungin sodium) for injection by intravenous infusion for the treatment of pediatric patients 4 months and older. Mycamine is currently approved in adults for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplants.
Plan B One-Step Available Without Prescription or Age Restrictions
The FDA has approved the use of Teva Women’s Health’s Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential. This action complies with the April 5, 2013, order of the U.S. District Court in New York to make levonorgestrel-containing emergency contraceptives available as a nonprescription product without age or point-of-sale restrictions.
Plan B One-Step is indicated to prevent pregnancy after known or suspected contraceptive failure or unprotected intercourse.
FDA Approves Fiorinal/Codeine #3 Black Box Warning
The FDA has approved a new Black Box Warning for Watson’s Fiorinal/Codeine #3 (codeine phosphate/aspirin/caffeine/butalbital) to alert health care providers that respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to CYP2D6 polymorphism. Fiorinal/Codeine #3 is indicated for relief of symptom complex of tension (or muscle contraction) headache.
Enteric-Coated Aspirin 81 mg Recall
Advance Pharmaceutical announced a voluntary recall of 1 lot (13A026, expiration date January 2015) of Rugby-labeled aspirin 81 mg enteric-coated tablets after receiving a complaint that a bottle actually contained acetaminophen 500 mg tablets. The labeled directions instruct patients to take 4 to 8 tablets every 4 hours, but not more than 48 tablets in 24 hours. Consumers who take 48 tablets daily of the defective product may be ingesting up to 24,000 mg of acetaminophen, which is about 6 times the maximum recommended daily dose of 4,000 mg.
Consumers with the affected lot should immediately discontinue its use and return it to the place of purchase. They should contact their physician or health care provider if they have experienced any problems that may be related to using this product.
Deaths Following Injection of Zyprexa Relprevv
The FDA is investigating 2 unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv (olanzapine pamoate). The patients died 3 to 4 days after receiving an appropriate dose of the drug.
Patients are required to receive the injection at a Risk Evaluation and Mitigation Strategy (REMS)–certified health care facility, to be continuously monitored at the facility for at least 3 hours following an injection, and to be accompanied home from the facility. The labeling contains warnings about the risk of postinjection delirium sedation syndrome. If therapy with Zyprexa Relprevv is started or continued in patients, health care providers should follow the REMS requirements and drug label recommendations.
New Indication for Xgeva
The FDA has approved Amgen’s Xgeva (denosumab) for the treatment of adults and some adolescents with giant cell tumor of the bone (GCTB). Xgeva is intended for patients whose GCTB cannot be surgically removed or when surgery is likely to result in severe morbidity, such as loss of limbs or joint removal. It should only be used in adolescents whose bones have matured. Xgeva is also indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.
Vecuronium Bromide for Injection Recall
Sagent Pharmaceuticals announced a voluntary nationwide recall of 3 lots (11I30481A, 11I30721A, and 11I32581A; distributed from January 2012 through May 2012) of vecuronium bromide for injection 10 mg (NDC number 25021-657-10) manufactured by MN Pharmaceuticals and distributed by Sagent. The recall is due to the discovery of an elevated impurity result detected during routine quality testing of stability samples at the 18-month interval. The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill patients with renal failure.
Sagent’s distributor, DDN, is notifying distributors and customers by fax, email, and certified mail and is arranging for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of, and return all recalled lots. Consumers should contact their health care provider if they have experienced any problems that may be related to taking or using this product. Any questions about returning unused product should be directed to the customer call center at 1-866-625-1618, Monday through Friday, 8 AM to 7 PM CST.
New Black Box Warning for Human Immune Globulin Products
The FDA is requiring manufacturers to add information on thrombosis to the current Black Box Warning in the labels of all intravenous human immune globulin products and to add a Black Box Warning to the labels of all subcutaneous and intramuscular human immune globulin products to highlight the risk of thrombosis and add information on its mitigation.
Health care providers should discuss with patients the risk of thrombosis associated with these products and carefully consider risk factors when selecting patients for treatment. Health care providers should monitor patients carefully for signs and symptoms of thrombosis at the time of infusion and after infusion and encourage patients to report any signs or symptoms.
Magnesium Sulfate Safety Alert
The FDA is advising health care providers against the use of magnesium sulfate injection for more than 5 to 7 days to stop preterm labor in pregnant women because a longer duration of administration may lead to low calcium levels and bone problems (eg, osteopenia, fractures) in the developing fetus. A new warning will be added to the label regarding the possible effect of this off-label use and the FDA Pregnancy Category will also be changed from A to D to convey that there is positive evidence of human fetal risk, but that potential benefits may warrant use of the drug in pregnant women despite potential risks. FDA-approved indications for magnesium sulfate include preventing seizures in patients with preeclampsia and controlling seizures in eclampsia.
FDA Approves Tafinlar, Mekinist, and Diagnostic Test for Melanoma
The FDA has approved 2 new drugs for the treatment of patients with advanced or unresectable melanoma. Tafinlar (dabrafenib) is a BRAF inhibitor approved to treat patients with melanoma whose tumors express the BRAF V600E gene mutation. Mekinist (trametinib) is an MEK inhibitor approved to treat patients whose tumors express the V600E or V600K gene mutations. Both drugs are manufactured by GlaxoSmithKline and are intended to be used as single agents. The FDA has also approved the THxID BRAF test, a companion diagnostic that will help determine if a patient’s melanoma cells have the V600E or V600K mutation in the BRAF gene.
Fresenius Kabi USA Recalls Magnesium Sulfate Injection
Fresenius Kabi USA has issued a voluntary recall of 1 lot (6103882) of magnesium sulfate injection because of the potential presence of glass particles in the vials. The recalled product is labeled with Product Code 6450 and is packaged as 500 mg/mL strength in 50 mL glass vials (25 vials per tray). The product was shipped in the US between May 30, 2012, and June 6, 2012, and has an expiration date of October 31, 2014. Customers who received the vials are being notified and instructed to return any unused product to their supplier.
New Indication for Amitiza
The FDA has approved Takeda Pharmaceuticals’ Amitiza (lubiprostone) for the treatment of opioid-induced constipation in adult patients with chronic, noncancer pain. Amitiza is also indicated for the treatment of chronic idiopathic constipation in adults and for the treatment of irritable bowel syndrome with constipation in women 18 years and older.
FDA Warns of Compounded Steroid Injections
The FDA is working closely with the Centers for Disease Control and Prevention and the Tennessee Board of Pharmacy to investigate 7 reports of adverse events associated with steroid injections compounded by Main Street Family Pharmacy of Newbern, TN. The reports are all from patients who received preservative-free methylprednisolone acetate (80 mg/mL) by injection and appear to be associated with a potentially contaminated medication. Clinical information is pending; at least 1 infection appears to be fungal.
The FDA recommends that health care providers not administer any products labeled as sterile from Main Street Family Pharmacy and quarantine them until further guidance is provided.
Sodium Phosphates Injection Crystallization Warning
All lots sodium phosphates injection single-dose vials manufactured by Luitpold Pharmaceuticals (distributed by American Regent) contain a saturated solution of sodium phosphates that may result in crystallization when stored at temperatures below the labeled storage conditions. If crystallization occurs after below-labeled storage, the potential exists for adverse events, including damage to blood vessels in the lung, localized swelling, and granuloma formation, after intravenous administration of crystals. As a preventive measure, American Regent is advising that the product be stored as directed and to avoid freezing or exposure to cold temperatures. In addition, the company is requiring that a filter must be used for withdrawal and administration of the product. If crystals/particles are observed, discard the product and contact American Regent’s Professional Services Department at 1-877-788-3232, Monday through Friday, 9 AM to 5 PM EST, or email at email@example.com.
For more information, see the news release.
Calcium Gluconate Particulate Warning
All lots of calcium gluconate injection 50 mL single-dose vials and 100 mL pharmacy bulk packages manufactured by Luitpold Pharmaceuticals (distributed by American Regent) may exhibit evidence of visible or subvisible particles not associated with the labeled precipitation that can occur. As a precautionary measure, the company is requiring that a filter must be used for the withdrawal and administration of the product. If precipitate or particulates are visible, discard the product and contact American Regent’s Professional Services Department at 1-877-788-3232, Monday through Friday, 9 AM to 5 PM EST, or email at firstname.lastname@example.org.
For more information, see the news release.
New Indication for Ilaris
The FDA has approved Novartis Pharmaceuticals’ Ilaris (canakinumab) injection for the treatment of systemic juvenile idiopathic arthritis in patients 2 years and older. Ilaris is also approved for the treatment of cryopyrin-associated periodic syndromes, including familial cold autoinflammatory syndrome and Muckle-Wells syndrome, in adults and children 4 years and older.
Methotrexate Sodium Injectable Vials Recall
Sandoz is conducting a voluntary nationwide recall to the hospital/user level of 2 lots (CL0996, expiration December 2013; CJ4948, expiration May 2013) of its methotrexate sodium 25 mg/mL, 40 mL injectable vials because of the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer.
Patients should immediately contact their health care provider as well as Sandoz to report an adverse reaction or quality problem involving this product. Contact Sandoz at 1-800-525-2492, 7 days a week, 24 hours a day, or at email@example.com.
New Black Box Warning for Codeine Sulfate
A new Black Box Warning has been added by the FDA to the labeling for codeine sulfate oral solution. The warning concerns the risk of respiratory depression and death in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a cytochrome P450 2D6 polymorphism. Codeine sulfate is indicated for the management of mild to moderately severe pain where the use of an opioid analgesic is appropriate.
Pentec Health Recalls Nutritional Prescriptions for Renal Patients
Pentec Health has issued a limited, voluntary recall of in-date nutritional prescriptions for renal patients. The recall is due to a lack of sterility assurance associated with 1 of its laminar flow hoods used in compounding. To date, the company has received no reports of injury or illness associated with any of the recalled prescriptions. Consumers or health care providers with questions regarding this recall may contact Pentec Health by phone at 800-223-4376, prompt 7, Monday through Friday, 9 AM to 8 PM EDT, or at firstname.lastname@example.org.
FDA Approves Generic Zomig Tablets
The FDA has approved Mylan’s zolmitriptan 2.5 and 5 mg tablets, the generic version of Zomig, indicated for the treatment of acute migraine with or without aura in adult patients.
New Indication Approved for Simponi
The FDA has approved Janssen Biotech’s Simponi (golimumab) for the treatment of moderately to severely active ulcerative colitis in adult patients who have demonstrated corticosteroid dependence or who have had an inadequate response to or did not tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine. Simponi is also indicated for the treatment of adults with active ankylosing spondylitis; active psoriatic arthritis (alone or in combination with methotrexate); and moderately to severely active rheumatoid arthritis (in combination with methotrexate).
FDA Approves Xofigo
The FDA has approved Bayer Healthcare’s Xofigo (radium RA 223 dichloride) injection for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
Zolpidem Label Changes
The FDA has approved label changes specifying new dosing recommendations for zolpidem tartrate products (Ambien, Ambien CR, and Edluar), the widely prescribed sleep medications, because of the known risk of next-morning impairment with these drugs. Ambien and Edluar are indicated for the short-term treatment of insomnia characterized by difficulties in sleep initiation. Ambien CR is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
The FDA also warns that patients who take extended-release zolpidem (Ambien CR), 6.25 or 12.5 mg, should not drive or engage in other activities that require complete mental alertness the day after taking the drug because zolpidem levels can remain high enough the next day to impair these activities. This new recommendation has been added to the Warnings and Precautions section of the package insert and to the patient Medication Guide for zolpidem extended release.
In January, the FDA required that recommended doses of zolpidem be lowered in women because blood levels may remain high enough that morning after use to impair activities that require alertness, including driving.
Atriphen Supplement Recall
Xymogen and the FDA are notifying consumers and health care providers of a recall of the dietary supplement Atriphen, a product sold for the support of healthy joint function. A third-party laboratory test confirmed the presence of undeclared allergens, soy and milk, in the product.
Consumers are urged to return this product for a full refund. More information is available at www.xymogen.com or via email at email@example.com.
FDA Approves Breo Ellipta for COPD
The FDA has approved Breo Ellipta (fluticasone furoate/vilanterol) inhalation powder for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.
Breo Ellipta carries a Black Box Warning stating that long-acting beta2-adrenergic agonists, such as vilanterol, increase the risk of asthma-related death. Breo Ellipta comes with a Medication Guide, should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm), and is not recommended for patients younger than 18 years.
Breo Ellipta was developed by GlaxoSmithKline in collaboration with Theravance.
Kadcyla Safety Alert
The FDA has notified health care providers that the use of the incorrect generic name for Genentech’s Kadcyla (ado-trastuzumab emtansine) in some medication-related electronic systems poses a risk of confusion with Genentech’s Herceptin (trastuzumab), resulting in potential medication errors and harm to patients due to different dosing and treatment schedules. Kadcyla is indicated as a single agent for the treatment of patients with human epidermal growth factor receptor 2 (HER2)–positive, metastatic breast cancer who previously received Herceptin and a taxane either separately or in combination.
New Black Box Warning for Pradaxa
The FDA is adding a new Black Box Warning for Pradaxa (dabigatran etexilate mesylate) concerning an increased risk of stroke when discontinuing use in patients without adequate continuous anticoagulation. The Boxed Warning states that discontinuing Pradaxa places patients at an increased risk of thrombotic events and that, unless it must be discontinued for a reason other than pathological bleeding, treatment with another anticoagulant should be considered. Pradaxa is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
FDA Approves Liptruzet
The FDA has approved Merck’s combination drug Liptruzet (ezetimibe/atorvastatin) as an adjunct to diet for the treatment of high low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia.
New Indication for Actemra
The FDA has approved Genetech’s Actemra (tocilizumab) injection for the treatment of polyarticular juvenile idiopathic arthritis in patients 2 years and older. Actemra is also indicated for the treatment of moderately to severely active rheumatoid arthritis in adults who have had inadequate response to 1 or more disease-modifying antirheumatic drugs, as well as for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years and older.
Safety Communication for Valproate
The FDA is advising health care providers that valproate sodium and related products valproic acid and divalproex sodium are contraindicated in pregnant women for the prevention of migraine headaches. Based on information from a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took the medications while pregnant. Stronger warnings about use during pregnancy will be added to the drug labels, and valproate will be changed from Category D (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to Category X (the risk of use in pregnant women clearly outweighs any possible benefit of the drug) for the indication of prevention of migraine headaches. Valproate will remain in Pregnancy Category D for treating epilepsy and manic episodes associated with bipolar disorder.
Expanded Indication for Sustiva
The FDA has approved an expanded indication for Bristol-Myers Squibb’s Sustiva (efavirenz) to include pediatric patients 3 months and older who weigh at least 3.5 kg. Sustiva is used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
FDA Approves Simbrinza
The FDA has approved Novartis’ Simbrinza (brimonidine 1%/brinzolamide tartrate 0.2%) suspension for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. Simbrinza is the only beta-blocker–free, fixed-dose therapy approved for glaucoma in the US.
FDA Approves Plan B One-Step Without a Prescription for Women 15 Years and Older
The FDA has approved Teva’s Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years and older. Plan B One-Step is an emergency contraceptive intended to reduce the possibility of pregnancy following unprotected sexual intercourse. Plan B One-Step will not stop a pregnancy when a woman is already pregnant, and there is no medical evidence that the product will harm a developing fetus. The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Packaging will include a product code prompting the cashier to request and verify the customer’s age, as well as a security tag to prevent theft.
FDA Approves Procysbi
The FDA has granted orphan drug designation to Raptor Pharmaceutical’s Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. A rare, life-threatening genetic condition that causes the protein building block cystine to build up in every cell of the body, nephropathic cystinosis is the most severe of three types of cystinosis.
Fenwal Recalls Anticoagulant Citrate Phosphate Dextrose Solution
Fenwal has initiated an urgent voluntary recall of 1 lot (FM13A15027, product code 4R1584) of Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK unit due to an error in which the platelet container is incorrectly labeled as “AS-1 Red Blood Cell Adenine-Saline added.” To date, there is only 1 reported occurrence and no safety concerns have been raised. Customers should check their inventory immediately, discontinue the use of this product, and return the impacted product to Fenwal.
FDA Limits Duration and Usage of Samsca
The FDA has determined that Otsuka America Pharmaceutical’s Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease, including cirrhosis, because it can cause liver injury, potentially leading to liver transplant or death. Samsca treatment should be stopped in patients who develop signs of liver disease. The FDA has worked with the manufacturer to revise the Samsca drug label to include new limitations.
Samsca is a selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium less than 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and syndrome of inappropriate antidiuretic hormone.
Patients should be made aware that Samsca may cause liver problems, including life-threatening liver failure, and that they should contact their health care provider to discuss any questions or concerns. Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program online, by returning the postage-paid FDA form 3500 by mail (to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or fax (1-800-332-0178).
Piperacillin/Tazobactam for Injection Recall
Apotex, on behalf of Hospira, is conducting a voluntary nationwide recall of 15 lots of piperacillin/tazobactam for injection 40.5 g (NDC 60505-0773-00, UPC 360505077304), packaged in 300 mL glass vials for reconstitution, to the hospital/health care provider/user level. The affected lots may show precipitation/crystallization in IV bag or IV line after reconstitution. The product was distributed nationwide in the US to wholesalers, distributors, HMOs, and home infusion and long-term care service providers.
Anyone with an existing inventory of the product should stop use and distribution, quarantine the recalled lots, and contact GENCO at 1-877-674-2078, Monday through Friday, 7 AM to 5 PM CST to arrange for return.
FDA Approves Kcentra
The FDA has approved CSL Behring’s Kcentra (prothrombin complex concentrate, human) for the urgent reversal of vitamin K antagonist anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the US.
Like plasma, Kcentra is used in conjunction with the administration of vitamin K to reverse anticoagulation effect and stop bleeding. Unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma.
Kcentra carries a Black Box Warning regarding the risk of blood clots. The warning also explains that patients receiving Kcentra should be monitored for signs and symptoms of thromboembolic events, as both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance.
Saratoga Therapeutics ebA Multivitamin Supplement Recall
Saratoga Therapeutics is recalling 900 bottles of ebA Multivitamin Supplement (lot 0912164, expiration date December 2012; lot 1110354, expiration date October 2014) because they may contain undeclared milk protein(s) and lactose, despite the label listing the product as free of milk components.
All customers should return any unused portion of the product to Saratoga Therapeutics for a refund. The company can be contacted at info@ebAMultivitamin.com or 215-661-9044, 8:30 AM to 4:30 PM EST.
Potiga Linked to Retinal Abnormalities, Skin Discoloration
The FDA is warning that Potiga (ezogabine) can cause eye abnormalities characterized by pigment changes in the retina, including scleral and conjunctival discoloration on the whites of the eyes and inside of eyelids, and can also cause blue skin discoloration, predominantly on or around the lips or in the nail beds of fingers or toes, although more widespread involvement of the face and legs has been reported. The skin discoloration generally occurred after 4 years of Potiga treatment, but appeared sooner in some patients. In some cases, retinal abnormalities were observed in the absence of skin discoloration. The FDA does not currently know if these changes are reversible. Potiga is indicated as adjunctive treatment for partial-onset seizures in adults.
The FDA recommends that all patients taking Potiga undergo a baseline eye exam and periodic eye exams that include visual acuity testing and dilated fundus photography; fluorescein angiograms, ocular coherence tomography, perimetry, and electroretinograms are also recommended. Patients who develop changes in vision or skin discoloration should contact their health care provider immediately.
Nora Apothecary & Alternative Therapies Recalls Sterile Compound Products
Nora Apothecary & Alternative Therapies has voluntarily recalled all sterile unexpired drug products compounded and dispensed by the pharmacy on or before April 19, 2013. The recall is due to concerns associated with quality control processes observed during a recent FDA inspection that present a lack of sterility assurance. To date, the company has received no reports of injury or illness associated with the use of their sterile products. Consumers or health care providers with questions regarding this recall should contact the manufacturer by phone at 800-729-0276 or 317-251-9547, Monday through Friday, 9:30 AM to 6 PM EST, or at firstname.lastname@example.org.
Balanced Solutions Compounding Pharmacy Recalls Sterile Products
Balanced Solutions Compounding Pharmacy has voluntarily recalled all lots of sterile unexpired products compounded by the pharmacy, due to concerns associated with quality control processes that present a lack of sterility assurance. During a recent inspection, the FDA identified gram-negative bacteria in the chromium chloride injection; however, the company has received no reports of injury or illness associated with the use their sterile products at this time. A list of the affected products can be found at www.bshrx.com.
The manufacturer will be notifying customers to arrange for product return to the pharmacy. Consumers or health care providers with questions regarding this recall should contact Balanced Solutions by phone at 407-936-2998 or 877-306-0008, Monday through Friday, 9:30 AM to 6 PM EST, or at email@example.com.
Samsca Indication Change
The FDA has approved a labeling change for Otsuka America’s Samsca (tolvaptan), indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium of less than 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH). Samsca is no longer indicated in patients with cirrhosis.
New Indication for AdreView
The FDA has approved GE Healthcare’s AdreView (iobenguane I 123) injection for scintigraphic assessment of sympathetic innervation of the myocardium in patients with New York Heart Association class II or III heart failure to identify those with lower 1- and 2-year mortality risks. AdreView is also indicated as an adjunct to other diagnostic tests for the detection of primary or metastatic pheochromocytoma or neuroblastoma.
ApothéCure Recalls Sterile Products
ApothéCure is voluntarily recalling all lots of sterile products compounded by the pharmacy that are not expired to the user level. The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes.
The sterile products include all injectables with the clear message, “Independently tested for sterility,” noted on the vials as well as the ApothéCure name.
Questions may be directed to ApothéCure at 800-969-6601 or 972-960-6601 from 9:30 AM to 6 PM CST, Monday-Friday, or at firstname.lastname@example.org.
NuVision Pharmacy Recalls Lyophilized Products
NuVision Pharmacy is voluntarily recalling all unexpired lots of lyophilized compounds HcG 5,000 units-5 mL and sermorelin/GHRH6 5 mL to the user level due to a lack of sterility assurance and concerns associated with the quality control processes identified during FDA inspection.
NuVision Pharmacy is notifying its customers by fax or email to return the products. Questions regarding this recall may be directed to NuVision Pharmacy at 800-914-7435, Monday-Friday from 10 AM to 6 PM CST, or at email@example.com. Patients who have received any product distributed by NuVision Pharmacy and have concerns should contact their healthcare provider.
Green Valley Drugs Recalls of All Lots of All Sterile Products
Green Valley Drugs has recalled all lots of all sterile products compounded, repackaged, and distributed products due to lack of sterility assurance and concerns associated with the quality control process. A full list of the recalled products can be found at greenvalleymed.com.
Health care providers should stop using all lots of sterile products and return them to the company. Questions may be directed to Green Valley Drugs at 702-564-2079 Monday-Friday, 9 AM to 5 PM PST, or firstname.lastname@example.org.
FDA Approves Diclegis for NVP
The FDA has approved Duchesnay USA’s Diclegis (doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg) delayed-release tablets for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management. Diclegis is to be taken daily and not on an as-need basis to help control symptoms throughout the day. Diclegis is expected to be available by the end of May 2013.
FDA Approves Prolensa
The FDA has approved Bausch + Lomb’s Prolensa (bromfenac) 0.07% ophthalmic solution for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
Bivigam Injection Recall
Biotest Pharmaceuticals is voluntarily recalling lot 120016 (expiration date March 31, 2014) of Bivigam (immune globulin intravenous [human]), 10% liquid injection after a routine inspection confirmed visible particles. Bivigam is indicated for the treatment of patients with primary humoral immunodeficiency.
All customers should discontinue distribution of the recalled lot and return all vials to Biotest’s Boca Raton, FL, facility (800-327-7106).
FDA Approves Generic Zovirax Ointment
The FDA has approved Mylan’s acyclovir 5% ointment USP, the generic equivalent to Zovirax ointment. Acyclovir ointment is indicated for the management of initial genital herpes and in limited non–life-threatening mucocutaneous herpes simplex virus infections in immunocompromised patients. Mylan intends to begin shipping the product immediately.
FDA Approves Karbinal ER
The FDA has approved Tris Pharma’s Karbinal ER (carbinoxamine maleate) extended-release 4 mg/5 mL oral suspension indicated for the treatment of seasonal and perennial allergic rhinitis in children 2 years and older. Tris Pharma plans to launch the product in the fall of 2013.
FDA Approves Invokana
The FDA has approved Janssen Pharmaceuticals’ Invokana (canagliflozin) tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Invokana belongs to a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors.
Sodium Chloride Injection Recall
Hospira is voluntarily recalling lot 25-037-JT (the lot number may be followed by a -01 or -90; expiration date January 1, 2015) of sodium chloride 0.9% injection in 1,000 mL flexible containers after a confirmed report of brass particulate containing copper, zinc, and lead found in the primary container in the form of small grey/brown particles.
All customers should discontinue the use and distribution of the recalled lot. Product returns can be arranged by contacting Stericycle at 1-888-480-2853, Monday through Friday, 8 AM to 5 PM EST. Replacement product from other lots is available.
FDA Approves Tecfidera for Multiple Sclerosis
The FDA has approved Biogen Idec’s Tecfidera (dimethyl fumarate) oral capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adults. Tecfidera will be available immediately for patient use.
FDA Approves TOBI Podhaler
The FDA has approved Novartis’ handheld TOBI Podhaler (tobramycin inhalation powder) device for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Tobramycin is also available as an inhalation solution for use via a nebulizer (TOBI) for the management of cystic fibrosis patients with P. aeruginosa.
Pallimed Solutions Voluntary Recall
Pallimed Solutions has voluntarily recalled all sterile compound products dispensed since January 1, 2013, to the user level, including all strengths, all doseforms, and all products within expiry date due to visible particulates in vials of several products. All products were distributed to patients and or physicians’ offices through Friday, March 22, 2013. Users should discontinue use and return the recalled products by contacting Pallimed at www.pallimed.com or by phone at 781-937-3344, Monday through Friday, 10 AM to 5 PM.
Any adverse events that may be related to the use of these products should be reported to the FDA’s MedWatch Adverse Event Reporting program online, by returning the postage-paid FDA form 3500 by mail (to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or fax (1-800-332-0178).
FDA Approves Aciphex Sprinkle for Pediatric Use
The FDA has approved Eisai Inc’s Aciphex Sprinkle (rabeprazole sodium) delayed-release capsules 5 and 10 mg for the treatment of gastroesophageal reflux disease (GERD) in children 1 to 11 years of age for up to 12 weeks. Rabeprazole is also indicated in adults for the short-term treatment and maintenance of healing of erosive or ulcerative GERD, the treatment of symptomatic GERD, the healing of duodenal ulcers, for the eradication of Helicobacter pylori to reduce the risk of recurrence of duodenal ulcers, and for the treatment of pathological hypersecretory conditions. Rabeprazole is indicated for the short-term treatment of symptomatic GERD in adolescent patients 12 years and older.
Med Prep Consulting Product Recall
Med Prep Consulting has notified the public that it is recalling all lots of all products compounded at its facility in Tinton Falls, NJ, due to lack of sterility assurance. The recall resulted from visible particulate contaminants, confirmed to be mold, in 50 mL bags of magnesium sulfate 2 g in dextrose 5% in water intravenous solution.
All affected products were packaged in plastic infusion bags, plastic infusion devices, plastic syringes, and glass vials, and distributed to hospital pharmacies in New Jersey, Pennsylvania, Connecticut, and Delaware. Products packaged only in plastic syringes were distributed nationwide. All products were distributed through March 13, 2013.
All facilities that received the products have been notified of the recall and instructed to remove and return affected products to the pharmacy. Questions about the recall should be directed to Med Prep Consulting at 732-493-3390, Monday through Friday, 10 AM to 5 PM EST.
Cerebyx Black Box Warning Added
The FDA has approved a new black box warning for Pfizer’s Cerebyx (fosphenytoin sodium) injection stating that the rate of intravenous Cerebyx administration should not exceed phenytoin 150 mg sodium equivalents per minute because of the risk of severe hypotension and cardiac arrhythmias. The warning also states that cardiac monitoring is needed during and after administration. Although the risk of cardiovascular toxicity increases with infusion rates above the recommended rate, these events have also been reported at or below the recommended rate. Reduction in rate of administration or discontinuation of dosing may be needed.
FDA Investigating Incretin Mimetic Drug Reports
The FDA is evaluating unpublished new findings that suggest an increased risk of pancreatitis and pancreatic duct metaplasia in patients with type 2 diabetes treated with incretin mimetics. These findings are based on pancreatic tissue samples taken from patients who died from unspecified causes. The FDA has requested these samples, as well as information on the methodology used to collect them, and will communicate its final conclusions and recommendations.
FDA Issues Warning for Azithromycin Heart Risks
The FDA has issued a safety warning that azithromycin (Zithromax or Zmax) may cause prolonged cardiac repolarization and QT interval, increasing the risk of cardiac arrhythmia and torsades de pointes. Patients at particular risk include those with known risk factors such as existing QT interval prolongation, a history of torsades de pointes, congenital long QT syndrome, uncompensated heart failure, use of drugs known to prolong the QT interval, uncorrected hypokalemia or hypomagnesemia, or clinically significant bradycardia.The warning results from FDA review of a research study and a subsequent study conducted by a manufacturer, both assessing the potential for azithromycin to cause abnormal cardiac activity.
Health care providers should be aware of the potential for QT interval prolongation and heart arrhythmias when prescribing or administering azithromycin for patients who are already at risk for cardiovascular events.
Expanded Indication for Corifact
The FDA has approved CSL Behring’s Corifact (human factor XIII concentrate) for the treatment of perioperative management of surgical bleeding in adult and pediatric patients with congenital factor XIII (FXIII) deficiency. Corifact is also indicated for the routine prophylactic treatment of congenital FXIII deficiency in adults and pediatric patients.
FDA Approves Osphena
The FDA has approved Shionogi’s Osphena (ospemifene), a selective estrogen receptor modulator, to treat postmenopausal women experiencing moderate to severe pain during sexual intercourse, a symptom of vulvar and vaginal atrophy due to menopause. Osphena is being approved with a boxed warning alerting women that the drug can stimulate the lining of the uterus and cause it to thicken. The boxed warning also provides the incidence rates of thrombotic and hemorrhagic stroke and deep vein thrombosis.
Stivarga Receives Orphan Drug Status, Expanded Indication
The FDA has granted orphan product designation to Bayer’s Stivarga (regorafenib) under the FDA’s priority review program to treat patients with advanced GI stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments. Stivarga is also approved for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an antivascular endothelial growth factor (VEGF) therapy, and, if KRAS wild type, an antiepidermal growth factor receptor (EGFR) therapy.
FDA Approves Generic Suboxone
The FDA has approved Actavis’ ANDA for buprenorphine hydrochloride/naloxone hydrochloride sublingual tablets 2 mg/0.5 mg and 8 mg/2 mg, the generic equivalent to Suboxone. Suboxone is indicated for maintenance treatment of opioid dependence. Actavis intends to begin shipping the product immediately.
FDA Approves Vituz
The FDA has approved Cypress’ Vituz (hydrocodone bitartrate/chlorpheniramine maleate) oral solution for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years and older.
FDA Stops Sensipar Trials
The FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after a recent patient death. The FDA continues to gather information on the circumstances surrounding the death and has not concluded whether or not Sensipar played a role. Sensipar is indicated in adults for the treatment of hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy, and for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
Omontys Injection Recall
Affymax and Takeda Pharmaceuticals are voluntarily recalling all lots of Omontys (peginesatide) injection as a result of postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. Omontys is indicated for the treatment adult patients with anemia due to chronic kidney disease who are on dialysis.
Dialysis organizations should discontinue use of Omontys. Customers will be provided with instructions on how to return the product to the manufacturer for a refund. For questions, call 1-855-466-6689, 9 AM to 5 PM EST, Monday through Friday.
FDA Approves Kadcyla for Breast Cancer
The FDA has approved Genentech’s Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer. Kadcyla is intended for patients who were previously treated with trastuzumab and taxanes.
Kadcyla is being approved with a black box warning alerting patients and health care providers that the drug can cause liver toxicity, heart toxicity, and death. The drug can also cause severe, life-threatening birth defects, and pregnancy status should be verified prior to starting treatment.
Expanded Indication for Epiduo
The FDA has approved Galderma Laboratories’ Epiduo (adapalene 0.1%/benzoyl peroxide 2.5%) gel for the treatment of acne in pediatric patients as young as 9 years. Epiduo was previously approved for patients 12 years and older.
New Indication for Zortress
The FDA has approved Novartis’ Zortress (everolimus) for the prophylaxis of organ rejection in adult patients receiving a liver transplant. Zortress is also approved for the prophylaxis of organ rejection in adult patients at low to moderate immunologic risk receiving a kidney transplant.
Vistide Voluntary Recall
Gilead Sciences is voluntarily recalling lot B120217A of Vistide (cidofovir injection) due to the discovery of particulate matter in some vials of the lot. Gilead is not aware of any complaints attributable to the particles. Vistide is indicated for the treatment of cytomegalovirus retinitis in patients with AIDS. Patients should contact their health care provider if they experience any problems that may be related to Vistide use.
Health care providers with questions regarding this recall can contact Gilead Medical Information at 1-800-445-3235, Monday through Friday 8 AM to 5 PM PST.
Lenvatinib Granted Orphan Designation
The FDA has granted Eisai’s lenvatinib (E7080), a small molecule tyrosine kinase inhibitor, orphan drug designation for the treatment of follicular, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer.
FDA Approves Versacloz
The FDA has approved Jazz Pharmaceuticals’ Versacloz (clozapine) 50 mg/mL oral suspension. Clozapine is indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at long-term risk for reexperiencing suicidal behavior, based on history and recent clinical state; and for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatment for schizophrenia.
Copegus Indication Expanded
The FDA has expanded the indication for Genentech’s Copegus (ribavirin) tablets to include pediatric patients 5 years and older with chronic hepatitis C virus infection who have compensated liver disease and have not previously been treated with interferon alpha. The indication was previously only for adults. Copegus is used in combination with peginterferon alfa-2a.
FDA Approves Pomalyst
The FDA has granted orphan product designation to Celegene’s Pomalyst (pomalidomide), an immunomodulator, under the accelerated approval program. Pomalyst is indicated for the treatment of relapsed and refractory multiple myeloma in patients who have received at least 2 prior therapies, including lenalidomide and bortezomib. Pomalyst carries a boxed warning alerting that the drug may cause blood clots and should not be used in pregnant women because it can cause severe, life-threatening birth defects. Because of the embryo-fetal risk, Pomalyst is available only through a risk evaluation and mitigation strategy (REMS) program.
Apocept Granted Orphan Designation
The FDA has granted Apogenix GmbH’s Apocept (APG101), a CD95-Fc fusion protein, orphan drug designation for the treatment of myelodysplastic syndromes (MDS). Apocept was previously granted orphan drug designation for the treatment of glioblastoma.
FDA Approves Testosterone Gel 1%
The FDA has approved Perrigo’s testosterone gel 1% indicated to treat adult males who have low or no testosterone. Perrigo’s testosterone gel is comparable with AbbVie’s AndroGel 1%.
Prevnar 13 Indication Expanded
The FDA has approved Pfizer’s Prevnar 13 (pneumococcal 13-valent conjugate vaccine) for use in vaccine-naive children and adolescents 6 to 17 years of age for active immunization for the prevention of invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine. Prevnar 13 is also indicated for the same use in children 6 weeks through 5 years of age and in adults 50 years and older. It is also indicated for the prevention of pneumonia in adults 50 years and older, and for the prevention of otitis media caused by certain Streptococcus pneumoniae serotypes in children 6 weeks through 5 years of age.
FDA Approves Generic Doxil
The FDA has approved Sun Pharma Global’s doxorubicin hydrochloride liposome injection, the first generic version of the cancer drug Doxil, which is currently on the FDA’s drug shortage list. The FDA had previously allowed temporary importation of Sun Pharma Global’s Lipodox (doxorubicin hydrochloride liposome), an alternative to Doxil that is not approved in the US, to ease the Doxil shortage. Doxil is indicated for the treatment of AIDS-related Kaposi sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy; in combination with bortezomib for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least 1 prior therapy; and for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. The generic product will be available in 20 and 50 mg vials.
Complera Indication Restricted
The FDA has approved labeling changes for Gilead’s Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) to restrict the indication to treatment-naive adults with HIV-1 RNA less than or equal to 100,000 copies/mL. Complera was previously indicated for treatment-naive adults regardless of HIV-1 RNA level.
FDA Approves Ravicti
The FDA has granted orphan drug designation to Hyperion Therapeutics’ Ravicti (glycerol phenylbutyrate) liquid under the fast track program for the chronic management of some urea cycle disorders in patients 2 years and older. Ravicti is intended for patients whose urea cycle disorder cannot be managed by amino acid supplements or a protein-restricted diet alone.
Tamiflu Dosing Error Warning
The Institute for Safe Medication Practices (ISMP) has issued a safety warning regarding a potential for dosing errors related to the compounding of Tamiflu oral suspension. A commercially prepared 6 mg/mL oral suspension in 60 mL bottles is available, but because this product has been on intermittent backorder, Genentech now provides a recipe for compounding the 6 mg/mL oral suspension from 75 mg capsules. However, unless prescribers specify a patient’s dose in milligrams (not volume), a dosing error is possible due to the fact that the manufacturer decreased the commercially available strength from 12 mg/mL to 6 mg/mL last year. The potential risk of dosing errors is further enhanced by Genentech’s previously recommended preparation of a 15 mg/mL compounded suspension. Prescribers should be made aware to express Tamiflu dosing in milligrams and compounding recipes updated to reflect the change.
Kynamro Granted Orphan Designation
The FDA has approved Isis Pharmaceuticals’ Kynamro (mipomersen sodium) injection as an adjunct to lipid-lowering medications and diet to treat homozygous familial hypercholesterolemia, a rare inherited disorder that causes extremely high cholesterol levels. The label for Kynamro will include a boxed warning about potential liver damage.
3 New Type 2 Diabetes Therapies Approved
The FDA has approved Takeda Pharmaceuticals’ Nesina (alogliptin), Oseni (alogliptin/pioglitazone), and Kazano (alogliptin/metformin hydrochloride) for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise. Oseni carries a boxed warning alerting patients of an increased risk of congestive heart failure; Kazano carries a boxed warning regarding increased risk of lactic acidosis. All 3 products are expected to launch in summer 2013.
New Indication for Gleevec
The FDA has approved Novartis’ Gleevec (imatinib) for the treatment of children with newly diagnosed Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). Gleevec is also approved to treat relapsed or refractory Ph+ ALL, aggressive systemic mastocytosis, dermatofibrosarcoma protuberans, GI stromal tumors, hypereosinophilic syndrome and/or chronic eosinophilic leukemia, and myelodysplastic/myeloproliferative diseases in adults, as well as Ph+ chronic myeloid leukemia in adults and pediatric patients.
FDA Approves Nonprescription Oxytrol for Women
The FDA has approved Merck’s Oxytrol for Women (oxybutynin chloride) patch as a nonprescription treatment for overactive bladder in women 18 years and older. Oxytrol will remain available to men by prescription only. Oxybutynin chloride is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Samsca Warning for Potential Liver Injury
Otsuka and the FDA have notified health care providers of significant liver injury associated with Samsca (tolvaptan) tablets. The warning is based on findings indicating that Samsca may cause irreversible and potentially fatal liver injury.
Health care providers should perform liver tests promptly in patients who report symptoms of liver injury and, if suspected, Samsca should be promptly discontinued. Samsca should not be reinitiated in patients unless the cause for the observed liver injury is definitively established to be unrelated to the drug.
FDA Expands Indication for Kaletra
The FDA has expanded the indication of Abbott Laboratories’ Kaletra (lopinavir/ritonavir) for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older in combination with other antiretroviral agents. Kaletra was previously approved for use in adults and pediatric patients 6 months and older.
New Indication for Exjade
The FDA has approved Novartis’ Exjade (deferasirox) for the treatment of patients 10 years and older who have chronic iron overload resulting from non–transfusion-dependent thalassemia (NTDT). Exjade is also approved for the treatment of patients 2 years and older with chronic iron overload caused by blood transfusions.
New Indication for Botox
The FDA has approved Allergan Dermatologics’ Botox (onabotulinumtoxinA) injection for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in adults who have an inadequate response to or are intolerant of an anticholinergic medication. Botox is also indicated for axillary hyperhidrosis, cervical dystonia, chronic migraine, strabismus and blepharospasm associated with dystonia, upper limb spasticity, and urinary incontinence.
FDA Approves Flublok
The FDA has approved Protein Sciences’ Flublok, a recombinant vaccine for seasonal influenza, for people 18 to 49 years of age. Approval for all people 18 years and older is expected later in 2013.
Unlike other influenza vaccines, Flublok is produced without live influenza virus or eggs. It has 3 times the active ingredient of traditional influenza vaccines and contains no preservatives (thimerosal), antibiotics, or adjuvants.
Flublok is currently available in limited supply, but will be widely available for the 2013-2014 influenza season.
FDA Approves Zecuity Migraine Patch
The FDA has approved NuPathe’s Zecuity (sumatriptan iontophoretic transdermal system) for treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan through the skin and is expected to be available in the fourth quarter of 2013.
Ferrous Sulfate Tablets Recall
Advance Pharmaceutical notified the public of a recall of 1 lot (12G468, expiration date July 2014) of ferrous sulfate tablets 325 mg after notification by a pharmacist that a bottle contained meclizine hydrochloride 25 mg tablets. The lot was manufactured and packaged in 100-count bottles under the label of Rugby Natural Iron Supplement Ferrous Sulfate.
Consumers who have the affected lot should not take the product and contact Advance Pharmaceutical at 631-981-4600, ext. 300, Monday through Friday, 8:30 AM to 4:30 PM EST.
New Didanosine Doseforms Approved
The FDA has approved didanosine 2 and 4 g for oral solution and didanosine 100, 150, and 200 mg tablets for oral suspension. Didanosine is indicated for the treatment of HIV-1 infection in adults and children in combination with other antiretroviral agents.
FDA Approves Uceris
The FDA has approved Santarus’ Uceris (budesonide) 9 mg extended-release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis. Uceris will be available in March 2013.
Telintra Granted Orphan Designation
The FDA has granted orphan drug designation to Telik’s Telintra (ezatiostat hydrochloride) for the treatment of myelodysplastic syndrome (MDS). Telintra is an investigational agent developed for the treatment of MDS and idiopathic neutropenia; it is a novel inhibitor of the enzyme glutathione S-transferase P1 1, leading to activation of Jun kinase, a key regulator of cellular growth and differentiation of blood precursor cells. Telintra has been shown to result in clinically significant and sustained reduction in red blood cell transfusions, transfusion independence, and multilineage responses in MDS patients.
Mitosol Kit Recalled
Mobius Therapeutics has voluntarily recalled of 2 lots of its Mitosol (mitomycin for solution) 0.2 mg/vial kit for ophthalmic use. The company cannot exclude the possibility that lots M098260 and M086920 (distributed between October 22, 2012, and December 14, 2012) may contain a strain of yeast on 1 or more parts in the kit; these lots should be considered nonsterile and unsafe for use. Use of these products could result in serious eye problems/infections, including possible blindness.
Mobius has not received any report of adverse events related to this recall. Customers with affected product should stop using it immediately and contact Mobius at 1-877-393-6484, option 2, for product return.
Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program online, by returning the postage-paid FDA form 3500 by mail (to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or fax (1-800-332-0178).p>
FDA Requires Lower Zolpidem Doses
The FDA is requiring that the recommended doses of zolpidem be lowered in women because blood levels may remain high enough the morning after use to impair activities that require alertness, including driving. Women appear to be more sensitive to this effect because they eliminate zolpidem more slowly than men, although the agency is also recommending that the lower doses be considered for men. The recommendation is focused on zolpidem products approved for use immediately before bedtime, including Ambien, Ambien CR, Edluar, and Zolpimist and their generic equivalents. The FDA is recommending that the doses for immediate-release products be lowered from 10 mg to 5 mg and from 12.5 mg to 6.5 mg for extended-release products in women.
FDA Expands Kineret Indication
The FDA has expanded the indication for Sobi’s Kineret (anakinra) to include the treatment of neonatal-onset multisystem inflammatory disease (NOMID). Kineret is also indicated for the reduction in signs and symptoms and slowing the progression of structural damage of moderately to severely active rheumatoid arthritis (RA) in patients 18 years and older who have failed 1 or more disease-modifying antirheumatic drugs (DMARDs). Anakinra can be used alone or in combination with DMARDs other than tumor necrosis factor (TNF)–blocking agents.
Terlipressin Granted Orphan Designation
The FDA has announced orphan drug designation for PharmaIN’s and LAT Pharma’s terlipressin for the treatment of ascites due to all etiologies except cancer. The companies’ drug candidate PHT101 (or PGC-C12E-terlipressin) incorporates drug delivery technologies that may enable once-daily subcutaneous injection administration dosing in outpatient populations with chronic ascites.
FDA Announces Orphan Designation for OrbeShield
The FDA has announced orphan drug designation for Soligenix’s OrbeShield (oral beclomethasone 17, 21-dipropionate [BDP]) for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster. OrbeShield is being developed for the treatment of acute GI radiation syndrome.
Generic Maxalt and Maxalt MLT Tablets Approved
Mylan Pharmaceuticals has received FDA approval for generic versions of Maxalt (rizatriptan benzoate) 5 and 10 mg tablets and Maxalt MLT (rizatriptan benzoate) 5 and 10 mg orally disintegrating tablets. Both drugs are indicated for the treatment of migraine with or without aura in adults and pediatric patients 6 to 17 years of age.
FDA Approves Eliquis
The FDA has approved Bristol-Myers Squibb’s Eliquis (apixaban), a factor Xa inhibitor anticoagulant, to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
FDA Approves Fulyzaq
The FDA has approved Napo Pharmaceuticals’ Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy. Fulyzaq is intended for use in HIV/AIDS patients with diarrhea not caused by an infection from a virus, bacteria, or parasite.
Sirturo Granted Accelerated Approval for TB
The FDA has granted accelerated approval to Janssen Therapuetics’ Sirturo (bedaquiline), a diarylquinoline antimycobacterial, for the treatment of pulmonary multidrug-resistant tuberculosis as part of combination therapy in adults. Sirturo labeling includes boxed warnings regarding increased risk of death and occurrence of QT prolongation.
New Indication for Adrenalin
The FDA has approved JHP Pharmaceuticals’ Adrenalin (epinephrine) injection for the induction and maintenance of mydriasis during intraocular surgery. Adrenalin is also approved for the emergency treatment of allergic reactions (type 1), including anaphylaxis.
Hydrocodone Bitartrate and Acetaminophen Tablets Recalled
Mylan announced a voluntary nationwide recall of 3 lots (3037841, 3040859, 3042573) of hydrocodone bitartrate 10 mg/acetaminophen 500 mg tablets because of the potential for bottles to contain tablets that have a higher dose of acetaminophen than that indicated on the label. The 3 lots were manufactured by Qualitest Pharmaceuticals, repackaged by Mylan, and distributed between February 20, 2012, and November 19, 2012. Consumers with the affected lots should contact Qualitest at 1-800-444-4011. Pharmacists and wholesalers should call MedTurn at 1-800-597-5952 for instructions on product return.
FDA Approves Juxtapid
The FDA has approved Aegerion’s Juxtapid (lomitapide) for the treatment of homozygous familial hypercholesterolemia as an adjunct to a low-fat diet and other lipid-lowering treatments, with or without LDL apheresis. Because Juxtapid labeling includes a boxed warning citing the risk of hepatic toxicity, it will be available through a risk evaluation and mitigation strategy (REMS) program.
Expanded Indication for Tamiflu
The FDA has expanded the approved use of Tamiflu (oseltamivir) for the treatment children as young as 2 weeks old who have shown symptoms of influenza for no longer than 2 days. Tamiflu is also indicated to treat adults infected with influenza who have shown symptoms for no longer than 2 days, and to prevent influenza in adults and in children 1 year and older. For more information, see the FDA’s website.
FDA Approves Gattex for Short Bowel Syndrome
The FDA has approved Nycomed’s Gattex (teduglutide) for the treatment of short bowel syndrome (SBS) in adults who need additional nutrition from intravenous feeding (parenteral nutrition). The drug is being approved with a risk evaluation and mitigation strategy (REMS) consisting of a communication plan and training for prescribers.
FDA Approves Bivigam
The FDA has approved Biotest’s Bivigam (immune globulin intravenous [human] 10%) for the treatment of primary humoral immunodeficiency, including humoral defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. The company plans to begin commercial shipments soon.
Pradaxa Contraindicated with Mechanical Prosthetic Heart Valves
The FDA issued a Drug Safety Communication warning against the use of the anticoagulant Pradaxa (dabigatran etexilate mesylate) in patients with mechanical heart valves. In the RE-ALIGN clinical trial, patients taking Pradaxa were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were patients taking warfarin, as well as more bleeding after valve surgery. Therefore, FDA is requiring a contraindication for Pradaxa in patients with mechanical heart valves. Patients taking Pradaxa who have these valves or valves made of natural biological tissue to another medication should be immediately transitioned to another medication.
New Black Box Warning for Incivek
The FDA is adding a boxed warning for Incivek (telaprevir) concerning fatal and nonfatal skin reactions, including Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), in patients taking the drug in combination with peginterferon alfa and ribavirin (Incivek combination treatment). The boxed warning states that Incivek combination treatment must be discontinued immediately in patients experiencing SJS, DRESS, or TEN, and that consideration should also be given to discontinuing any other medications that may be associated with serious skin reactions. Patients with serious skin reactions should also receive urgent medical care. Incivek is indicated for the treatment of chronic hepatitis C in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease, including cirrhosis. For more information, see the FDA’s website.
Zicam Extreme Congestion Relief Nasal Gel Recalled
Matrixx Initiatives’ is recalling 1 lot (2J23, expiration 09/15) of Zicam Extreme Congestion Relief nasal gel because of the detection of Burkholderia cepacia in a single sample of the product taken from the affected lot. Tests on additional samples from the same lot have shown no evidence of the organism. B. cepacia in a nasal spray could cause upper airway colonization which may secondarily lead to respiratory infections in individuals with a compromised immune system or those with chronic lung conditions, such as cystic fibrosis. Matrixx is arranging for return of all recalled products. For more information see the press release.
FDA Approves Signifor
The FDA has granted orphan drug status to Novartis’ Signifor (pasireotide diaspartate) injection for the treatment of Cushing disease in adult patients for whom pituitary surgery is not an option or has not been curative. Signifor will be dispensed with a patient Medication Guide.
Hospira Recalls Carboplatin Injection
Hospira is further informing the general public about a previously communicated voluntary user-level recall of 3 lots of carboplatin injection because of visible particulates identified during a retain sample inspection. The particles have been identified as carboplatin crystals, which, if injected into a patient, may obstruct blood vessels, causing local infarction, thromboembolism, and vasculitis. For more information, see the original story
FDA Adds New Contraindication to Xyrem (Sodium Oxybate)
The FDA has added a new contraindication against the concomitant use of Xyrem (sodium oxybate) with alcohol. Xyrem is already contraindicated with insomnia agents, and its use with other CNS depressant drugs, such as opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, general anesthetics, and muscle relaxants, should generally be avoided. The use of Xyrem with alcohol or CNS depressant drugs can impair consciousness and may lead to respiratory depression. After evaluating reports of death in patients taking Xyrem with alcohol or other CNS depressants, and given some of the circumstances noted in those deaths, the FDA determined that the recommendations in the Xyrem drug label should be strengthened to remind patients and health care providers of the risks associated with concomitant use. For label revisions, see the FDA’s website.
FDA Approves Raxibacumab for Inhalational Anthrax
The FDA has approved raxibacumab injection for the treatment inhalational anthrax. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or appropriate. The FDA granted raxibacumab fast track designation, priority review, and orphan product designation. It is the first monoclonal antibody approved under the FDA’s Animal Efficacy Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct trials in humans.
FDA Approves Iclusig
The FDA has granted orphan drug status to Ariad Pharmaceuticals’ Iclusig (ponatinib) under the accelerated approval program to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL), 2 rare blood and bone marrow diseases. The Iclusig package labeling includes a boxed warning alerting patients and health care providers that the drug can cause blood clots and liver toxicity.
Safety Review of Chantix Update
The FDA is informing the public about the results of a large meta-analysis of clinical trials comparing patients who received Pfizer’s smoking cessation drug, Chantix (varenicline), to patients who received a placebo. The FDA had required Pfizer to conduct the meta-analysis to further evaluate the cardiovascular safety of the drug after first notifying the public about a possible increased risk of cardiovascular adverse events with Chantix in June 2011. Although the occurrence of major adverse cardiovascular events (a combined outcome of cardiovascular-related death, nonfatal heart attack, and nonfatal stroke) was higher in patients using Chantix, the events were uncommon in both the Chantix and placebo groups. Even though the risk was not considered to be statistically significant, it is still uncertain whether excess risk in the Chantix group was due to the drug or to chance.
FDA Approves New Promacta Indication
The FDA has approved GlaxoSmithKline’s Promacta (eltrombopag) for the supportive treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Promacta is also approved for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The Promacta labeling includes a boxed warning concerning hepatoxicity and a Medication Guide. There is an increased risk of hepatic decomposition when eltrombopag is used in combination with interferon and ribavirin in patients with chronic hepatitis C.
FDA Expands Zytiga Indication
The FDA has expanded the indication for Janssen Biotech’s Zytiga (abiraterone), an oral, once-daily medication used in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer. Zytiga is now approved for use prior to treatment with chemotherapy; previously, it was approved for use only in patients whose prostate cancer progressed after treatment with docetaxel.
Protandim Dietary Supplement Recall
LifeVantage Corporation has issued a voluntarily recall of its dietary supplement Protandim, the Nrf2 Synergizer. The company is taking this action due to the possible inclusion of small metal fragments originally discovered in batches of turmeric extract, an ingredient in Protandim that was purchased from a third-party supplier. Protandim is marketed to combat oxidative stress and regulate the aging process.
The products (see http://www.fda.gov/Safety/Recalls/ucm331258.htm for lot numbers) were distributed between July and November 2012. Lot numbers are located on the left side of the front of the product label directly above the RFID scan bar.
Although LifeVantage has consulted with medical experts and believes these materials pose no serious health risk, consumers are encouraged to cease use of Protandim.
Hydrocodone Bitartrate/Acetaminophen Recall
Qualitest Pharmaceuticals has issued a voluntary, nationwide recall for 101 lots of hydrocodone bitartrate 10 mg/acetaminophen tablets 500 mg (lot numbers beginning with the letter “C” and NDC numbers 0603-3888-16, 0603-3888-20, 0603-3888-02, 0603-3888-21, 0603-3888-22, 0603-3888-26, 0603-3888-04, 0603-3888-28, and 0603-3888-32), distributed between February 20, 2012, and November 19, 2012, to wholesale distributors and retail pharmacies. Bottles from the affected lots may contain tablets with a higher dosage of acetaminophen.
Consumers should contact Qualitest at 1-800-444-4011, Monday through Friday 8 AM to 5 PM CST. Pharmacists and wholesalers should check their inventories for the affected lots, segregate any material from the lots, and contact MedTurn at 1-800-967-5952 for instructions on product return.
Heparin Label Change
The FDA has issued a notice about changes to heparin product labels in order to reduce the risk of miscalculations that may result in medication errors. Effective May 1, 2013, manufacturers will be required to clearly state the strength of the entire container of heparin followed in parentheses by the amount of the medication in 1 mL. In the interim, users should be aware that both current and revised heparin container labels will be available. Examples of current and revised heparin labels can be found online.
FDA Approves Generic Atacand HCT
Mylan Pharmaceuticals has received FDA approval for its generic version of Atacand HCT (candesartan and hydrochlorothiazide) 16/12.5 mg, 32/12.5 mg, and 32/25 mg tablets, indicated for the treatment of hypertension. Mylan is shipping all approved strengths immediately.
Ondansetron 32 mg IV to be Removed From Market
The FDA is notifying health care providers that ondansetron hydrochloride (Zofran) 32 mg, single intravenous dose will no longer be marketed because of the potential for QT prolongation, which can lead to torsades de pointes. The dose has been removed from GlaxoSmithKline’s Zofran drug label. The FDA is working with the manufacturers of all generic ondansetron 32 mg, single-dose injectable products to voluntarily recall them from the market. The FDA anticipates these products will be removed from the market by early 2013 and does not expect this recall to contribute to a drug shortage.
Generic Lipitor Recall Leads to Production Halt
Ranbaxy Pharmaceuticals has stopped production of atorvastatin calcium 10, 20, and 40 mg tablets, the generic version of Lipitor. The company recently recalled 41 lots at the retail level because the batches may contain small glass particles. Production has been halted until the company can determine the possible origin of glass particles in the tablets.
FDA Approves Cometriq for Thyroid Cancer
The FDA has approved Exelixis’ Cometriq (cabozantinib) to treat metastatic medullary thyroid cancer. Cometriq received orphan-product designation and was approved under the FDA’s priority review program. The prescribing information includes a boxed warning alerting patients and health care providers that severe and fatal bleeding, as well as GI perforations and fistula formation occurred in some patients.
Isovue Voluntary Recall
Bracco Diagnostics is voluntarily recalling 9 lots of Isovue (iopamidol injection) prefilled power injector syringes because of the presence of visible particles that have the potential to cause adverse health consequences. The affected lots were distributed from January 21, 2010, to May 9, 2012, to wholesalers and distributors nationwide. For a full list of affected products, see the press release. To return the affected products, contact Stericycle, Bracco’s contractor for the recall, at 1-866-201-9133, Monday through Friday 8 AM to 5 PM EST.
Generic Lipitor Recall
Ranbaxy Pharmaceuticals is recalling bottles of atorvastatin calcium 10, 20, and 40 mg tablets, the generic version of Lipitor, because the batches may contain small glass particles. A total of 41 lots of 90- and 500-count bottles are being recalled at the retail level. A full list of recalled lot numbers can be found online.
New Indication Approved for Promacta
The FDA has approved GlaxoSmithKline’s Promacta (eltrombopag) for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. Promacta is the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based therapy because of low blood platelet counts. Promacta is also indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
New Indication for Viramune XR
The FDA has approved Boehringer Ingelheim Pharmaceuticals’ Viramune XR (nevirapine) for the treatment of HIV-1 infection in pediatric patients ages 6 to less than 18 years of age. Viramune XR is also indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
FDA Updates Immune Globulin Product Safety Information
The FDA has issued an updated Safety Communication regarding thrombotic events and hemolysis potentially associated with the administration of human immune globulin. Because thrombosis has previously been identified as a potential risk following human immune globulin administration, the agency continues to investigate whether specific characteristics of these products account for an increased risk. FDA scientists and product manufacturers have examined different lots of immune globulin products and found elevated levels of the activated clotting factor XIa in certain lots produced by different manufacturers. Higher levels of factor XIa were associated with a greater incidence of arterial and venous clot formation in patients receiving these products.
Acute intravascular hemolysis or delayed hemolytic anemia can also occur after immune globulin therapy. In some cases, this happens because immune globulins contain blood group antibodies that can act as hemolysins by coating red blood cells, causing a positive direct antibody (Coombs) test result and hemolysis. Isolated cases of hemolysis-related renal dysfunction/failure or disseminated intravascular coagulation have also been reported following treatment with immune globulins.
For more information, go to the FDA’s website.
Amatuximab Granted Orphan Designation
The FDA has granted orphan drug designation to Morphotek’s investigational cancer drug, amatuximab, a chimeric IgG1 antibody, for the treatment of malignant pleural mesothelioma.
FDA Approves Xeljanz for Rheumatoid Arthritis
The FDA has approved Pfizer’s Xeljanz (tofacitinib) for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response to, or who are intolerant of, methotrexate. Xeljanz can be used alone or in combination with methotrexate and certain other treatments. It is the first rheumatoid arthritis treatment from a new class of pain medications called Janus kinase (JAK) inhibitors, which interfere with enzymes in the body that contribute to tissue inflammation. Xeljanz has a boxed warning to alert prescribers and patients about the increased risk of serious infections, including opportunistic infections, tuberculosis, cancers, and lymphoma, and is also associated with increases in cholesterol and liver enzyme tests as well as decreases in blood counts. Xeljanz will be dispensed with a patient Medication Guide.
FDA Evaluates Serious Bleeding with Pradaxa Use
The FDA has released a report evaluating new information about the risk of serious bleeding associated with use of anticoagulants Pradaxa (dabigatran), indicated for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and warfarin. The results indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than those associated with the new use of warfarin. The FDA has not changed its recommendations regarding Pradaxa, but will continue to evaluate multiple sources of data in the ongoing safety review of this issue. Health care professionals who prescribe Pradaxa should carefully follow the dosing recommendations in the drug label, especially for patients with renal impairment, to reduce the risk of bleeding. The FDA report did not address the current lack of an antidote to reverse the blood-thinning effects of Pradaxa.
FDA Approves Expanded Indication for Xarelto
The FDA expanded the approved use of Xarelto (rivaroxaban) to include the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment. Xarelto is currently approved to reduce the risk of DVT and PE after knee or hip replacement surgery, and to reduce the risk of stroke in people with non-valvular atrial fibrillation.
Fungal Meningitis Outbreak Update
Laboratory results from samples of 2 additional recalled New England Compounding Center (NECC) products (preservative-free betamethasone and cardioplegia solution) have tested positive for bacterial contamination. FDA and the Centers for Disease Control and Prevention (CDC) laboratories have identified bacteria present in 3 separate lots of preservative-free betamethasone, with each lot producing different culture results, and in a single lot of cardioplegia solution. These results reinforce the FDA’s previously issued guidance that hospitals, clinics, and health care providers should not use any NECC-supplied products.
Information about the outbreak is available by calling the FDA’s Division of Drug Information at 855-543-3784 or sending an email to email@example.com.
Ameridose Recalls All Products
Ameridose, based in Westborough, MA, is voluntarily recalling all of its unexpired products in circulation due to the FDA’s current inspection of the company’s facility as part of the agency’s ongoing fungal meningitis outbreak investigation. Ameridose shares common management with the New England Compounding Center (NECC) of Framingham, MA, the firm originally linked to the ongoing fungal meningitis outbreak. The FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility. The recall is not based on reports of patients with infections associated with any Ameridose products, but health care professionals should stop using the recalled products and return them. Ameridose can be contacted at 888-820-0622 for return instructions. A complete list of all recalled Ameridose products can be accessed here.
Nefazodone Warnings Revised
Teva Pharmaceuticals has announced changes to the product labeling for nefazodone, indicated for the treatment of depression. Information about the risk of suicidal thinking and behavior in certain patients has been added to the boxed warning. A warning restating the risk of hepatic failure associated with nefazodone has also been added to the indications section, which could lead to the conclusion by health care providers that other drugs should be considered first in the treatment of depression.
FDA Approves Synribo for Chronic Myelogenous Leukemia
The FDA has granted orphan drug designation to Teva Pharmaceuticals’ Synribo (omacetaxine mepesuccinate) injection under the accelerated approval program to treat adults with chronic myelogenous leukemia. Synribo is intended to be used in patients whose cancer progressed after treatment with at least 2 tyrosine kinase inhibitors.
Safety Alert: Accidental Ingestion of Eye Drops/Nasal Spray in Children
The FDA has issued a safety announcement alerting the public that accidental ingestion of OTC eye drops and decongestant nasal sprays by children may result in serious harm. These products are typically used to relieve eye redness or nasal congestion and contain tetrahydrozoline, oxymetazoline, or naphazoline as active ingredients. The nasal sprays and eye drops are sold under various brand names and as generic and store brand products. Serious adverse reactions requiring hospitalization (including coma, decreased heart rate, decreased breathing, and sedation) have been reported in children 5 years and younger after ingestion of even very small amounts (as little as 0.6 mL). These medications should be stored out of the reach of children at all times. In case of accidental ingestion of these products (see product list) contact the Poison Control Center at 1-800-222-1222 and seek emergency medical care immediately.
FDA Provides Customer Lists for Fungal Meningitis Outbreak
The FDA is making available 2 lists of customers who received products shipped on or after May 21, 2012, from the New England Compounding Center’s (NECC) Framingham, MA, facility. The first list provides customer names and addresses, organized by state. The second list includes the same basic information, but is organized alphabetically by customer name with the products, quantities, and dates shipped. The lists were prepared using information provided by the NECC; however, the FDA cannot vouch for their completeness or accuracy.
The FDA is reiterating and updating its previous recommendation so that health care providers can focus attention on following up with patients most at risk of having received a contaminated product. These patients include those who received an injectable product (including an ophthalmic injectable drug or drug used in conjunction with eye surgery) or a cardioplegic solution purchased from or provided by the NECC, and shipped and administered on or after May 21, 2012.
FDA Approves Fycompa for Seizures
The FDA has approved Eisai’s Fycompa (perampanel) tablets to treat partial onset seizures in patients 12 years and older with epilepsy. Fycompa’s label has a boxed warning to alert prescribers and patients about the risk of serious neuropsychiatric events, including irritability, aggression, anger, anxiety, paranoia, euphoric mood, agitation, and mental status changes. Some of these events were reported as serious and life threatening. Violent thoughts or threatening behavior was also observed in a few patients. Patients and caregivers should notify a health care professional immediately if atypical changes in mood or behavior are observed. Health care professionals should closely monitor patients during the titration period when higher doses are used. Fycompa will be dispensed with a patient Medication Guide.
FDA Releases Patient Letter on Fungal Meningitis Outbreak
The Centers for Disease Control and Prevention and the FDA have confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate (80 mg/mL) from 1 (08102012@51, expiration date February 6, 2013) of the 3 implicated lots from the New England Compounding Center (NECC). The laboratory confirmation further links steroid injections from these lots to the multistate outbreak of fungal meningitis and joint infections. Testing on the other 2 implicated lots of methylprednisolone acetate and other NECC injectables continues.
A Patient Notification Letter template is now available on the FDA "Update on Fungal Meningitis" webpage under the "Related Information" section for health care providers notifying patients who were administered a recalled drug.
FDA Approves Jetrea
The FDA has approved ThromboGenics’ Jetrea (ocriplasmin), a proteolytic enzyme, for the treatment of symptomatic vitreomacular adhesion (VMA). Jetrea is the first FDA-approved drug for VMA. The most common side effects reported in patients treated with Jetrea include eye floaters; bleeding of the conjunctiva; eye pain; flashes of light (photopsia); blurred vision; unclear vision; vision loss; retinal edema; and macular edema.
FDA Approves Bethkis for Cystic Fibrosis
FDA Issues Safety Statement on Fungal Meningitis Outbreak
The FDA previously issued guidance for medical professionals that all products distributed by the New England Compounding Center (NECC) should be retained, secured, and withheld from use.
Based on additional reports, the FDA is now advising health care providers to follow-up with patients who were administered any injectable medication from or produced by NECC, including injectable ophthalmic drugs used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC after May 21, 2012. Health care providers and medical care organizations should inform patients who received these NECC products of the symptoms of possible infection and instruct them to contact their health care provider immediately if they experience any of these symptoms.
FDA Approves Expanded Indication for Actemra
The FDA has approved a modified indication for Genentech’s Actemra (tocilizumab) for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to 1 or more disease-modifying antirheumatic drugs. Previously, this indication was for patients with an inadequate response to one or more tumor necrosis factor antagonist therapies. Tocilizumab is also indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years and older.
FDA Approves New Indication for Abraxane
The FDA has approved Celgene’s Abraxane (paclitaxel) injection for the first-line treatment of locally advanced or metastatic non–small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. Abraxane had previously been used off-label for this indication. Abraxane is also indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Previous therapy should have included an anthracycline unless clinically contraindicated.
Lactated Ringer’s and 5% Dextrose Injection Recall
The FDA has announced a voluntary recall of 1 lot (12-160-JT, expiration date December 1, 2013, NDC 0409-7929-09) of Hospira’s Lactated Ringer’s and 5% Dextrose Injection, USP, 1,000 mL Flexible Container. This action was prompted by 1 confirmed customer report of a leak in the primary container between the cobra cap and fill-tube seal, and in which a spore-like structured particulate, consistent with mold, was noted in the solution. Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-877-650-7688 (Monday-Friday, 8:00 AM-5 PM EST), to arrange for product return. Replacement product from other lots is available.
New England Compounding Center Recalls All Products
The New England Compounding Center (NECC) has expanded its voluntary nationwide recall to include all products compounded and distributed from its facility in Framingham, MA, in cooperation with an ongoing, multistate investigation conducted by the FDA, the Centers for Disease Control and Prevention (CDC), and the Massachusetts Department of Public Health (DPH) of Aspergillus meningitis among patients who received an epidural steroid injection. The outbreak is associated with potentially contaminated preservative-free methylprednisolone acetate (80 mg/mL). The FDA has recommended that all health care professionals cease use and remove from their pharmaceutical inventory any product produced by NECC. A complete list of all products subject to this recall can be accessed at here.
For questions regarding case definitions of A. meningitis, please contact the DPH Epidemiology Hotline: 617-983-6800.
Budeprion XL 300 mg Withdrawn
The FDA has reviewed new data that indicate that Budeprion XL 300 mg (bupropion hydrochloride extended-release tablets), manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals, is not therapeutically equivalent to GlaxoSmithKline's Wellbutrin XL 300 mg. The FDA has changed the therapeutic equivalency rating for this product from AB to BX.
Impax has requested that the FDA withdraw approval of Budeprion XL 300 mg extended-release tablets. Impax and Teva have stopped shipping the product and are issuing detailed information to their customers. This announcement relates only to Budeprion XL 300 mg manufactured by Impax and marketed by Teva; however, the FDA has asked the other manufacturers (Anchen, Actavis, Watson, and Mylan) to conduct studies to assess the bioequivalence of their generic versions of Wellbutrin XL 300 mg. The FDA has asked these companies to submit the study data no later than March 2013.
Patients taking Budeprion XL 300 mg as a substitute for Wellbutrin XL 300 mg should talk with their health care provider if they have questions about this medication.
FDA Approves Cystaran
The FDA has approved Sigma-Tau Pharmaceuticals’ Cystaran (cysteamine 0.44% ophthalmic solution) for the treatment of corneal cystine crystals in cystinosis patients.
FDA Approves Lotemax Gel
The FDA has approved Bausch & Lomb’s Lotemax (loteprednol 0.5% etabonate ophthalmic gel) for the treatment of postoperative inflammation and pain following ocular surgery.
Opaxio Granted Orphan Designation
The FDA has granted orphan status to Cell Therapeutics’ Opaxio (paclitaxel poliglumex) for the treatment of glioblastoma multiforme, a malignant brain cancer.
New Indication Approved for Humira
The FDA has approved Abbott’s Humira (adalimumab) for the treatment of moderate to severe ulcerative colitis in adults. Humira is approved to control ulcerative colitis when immunosuppressant medicines have not been effective. The drug is a tumor necrosis factor (TNF) that is also indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohns disease, and plaque psoriasis.
FDA Approves Quillivant XR
The FDA has approved NextWave Pharmaceuticals’ Quillivant XR (methylphenidate hydrochloride) for the treatment of attention deficit hyperactivity disorder (ADHD). Quillivant XR is the first once-daily, extended-release liquid methylphenidate available for patients with ADHD. Quillivant XR is expected to be available in January 2013.
FDA Approves Stivarga for Metastatic Colorectal Cancer
The FDA has approved Bayer’s Stivarga (regorafenib) for the treatment of patients with metastatic colorectal cancer who have been previously treated with FOLFIRI (fluoropyrimidine-, oxaliplatin-, and irinotecan)-based chemotherapy, an anti-VEGF (vascular endothelial growth factor) therapy, and, if KRAS wild type, an anti-EGFR (endothelial growth factor receptor) therapy.
Stivarga labeling will include a black box warning alerting that severe and sometimes fatal liver toxicity was observed in patients treated with the drug during clinical studies.
New Indication Approved for Prolia
The FDA has approved Amgen’s Prolia (denosumab) injection for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Prolia is also indicated for treatment of bone loss in men receiving androgen deprivation therapy for prostate cancer, treatment of postmenopausal women with osteoporosis at high risk for fracture, and treatment of bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer.
Exjade Black Box Warning Revised
Novartis has announced changes to the product label for Exjade (deferasirox), indicated for the treatment of chronic iron overload caused by blood transfusions (transfusional hemosiderosis) in patients 2 years and older. The boxed warning now states that use should be avoided in patients with severe hepatic impairment and that the dose should be reduced in patients with moderate hepatic impairment.
Hydrocodone Bitartrate and Acetaminophen Recall
Watson Laboratories has issued a voluntary, nationwide recall for 2 lots of hydrocodone bitartrate and acetaminophen tablets 10 mg/500 mg (519406A and 521759A, both with the expiration date April 2014), distributed between June 27, 2012, and July 18, 2012, to wholesale distributors and retail pharmacies.
A complaint was received that some tablets were thicker and darker in shade than other tablets, with the possibility that some of these tablets exceed weight specification and may contain higher-than-indicated amounts of hydrocodone bitartrate and/or acetaminophen.
Pharmacists and wholesalers should segregate any material from these lots and contact GENCO Pharmaceutical Services at 1-800-950-5479 for instructions on product return.