Safety Alerts & Recalls

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FDA Revises Recommendations for Heart Monitoring and Use of Multiple Sclerosis Drug Gilenya (Fingolimod)
The U.S. Food and Drug Administration (FDA) has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod). The FDA also has evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes. The FDA could not definitively conclude that Gilenya was related to any of the deaths. However, based on its reevaluation of the data, the FDA remains concerned about the effects the heart-related side effects of Gilenya after the first dose. Data show that, although the maximum heart rate lowering effect of Gilenya usually occurs within 6 hours of the first dose, the maximum effect may occur as late as 20 hours after the first dose in some patients. For this reason, the FDA now advises against the use Gilenya in patients with certain pre-existing or recent (within last 6 months) heart conditions or stroke, or who are taking certain antiarrhythmic medications. The FDA continues to recommend that all patients starting Gilenya be monitored for signs of a slow heart rate (bradycardia) for at least 6 hours after the first dose by monitoring hourly pulse and blood pressure measurements. The electrical activity of the heart should be measured with an electrocardiogram (ECG or EKG) prior to dosing and at the end of the observation period. In addition, the FDA is now recommending that the time of monitoring be extended past 6 hours in patients who are at higher risk for or who may not tolerate bradycardia. Extended monitoring should include continuous ECG or EKG monitoring that continues overnight. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm303192.htm
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FDA Reviews Long-Term Use of Bisphosphonate Bone Drugs
This week the New England Journal of Medicine published a Food and Drug Administration (FDA) review of bone-building medicines for osteopenia and osteoporosis (known as bisphosphonates) that looked to answer the question "How long women should continue using bisphosphonates?" Bisphosphonates are known by generic and brand names such as alendronate (Fosamax, Fosamax Plus D), ibandronate (Boniva), risedronate (Actonel, Actonel with Calcium, Atelvia), etidronate (Didronel), tiludronate (Skelid), and zoledronic acid (Reclast). As the FDA has announced in their previous safety updates, the concern is that after years of use, bisphosphonates may in rare cases actually lead to weaker bones in certain women and may contribute to rare but serious adverse events, including unusual femur fractures, esophageal cancer and osteonecrosis of the jaw, a painful and damaging breakdown of the jaw bone. This FDA review looked specifically at the risks of long-term use of bisphosphonates in osteopenia and osteoporosis. This review did not address the long-term use of bisphosphonates in other conditions. For more information, please visit: http://www.nejm.org/doi/full/10.1056/NEJMp1202619?query=featured_home&
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Date Published Title Drug Source
2012-05-14 FDA Revises Recommendations for Heart Monitoring and Use of Multiple Sclerosis Drug Gilenya (Fingolimod) Fingolimod FDA
2012-05-11 FDA Reviews Long-Term Use of Bisphosphonate Bone Drugs Ibandronate Sodium MediGuard CRT
2012-05-11 FDA Warns on Dangers of Unproven Treatment for Multiple Sclerosis Interferon Beta-1A FDA
2012-05-11 FDA Warns on Dangers of Unproven Treatment for Multiple Sclerosis FDA
2012-05-07 FDA Completes Safety Review of Cancer Drug Revlimid (lenalidomide) and Risk of Developing New Types of Cancers Lenalidomide FDA
2012-05-06 Novartis Consumer Health Recalls Excedrin, NoDoz, Bufferin, and Gas-X Prevention Products Manufacturer
2012-05-01 Vintage Pharmaceuticals Recalls Single Lots of Methylprednisolone, Tablets, 4 mg Methylprednisolone FDA
2012-05-01 Teva Pharmaceuticals USA Recalls Single Lot of Claravis 40 mg Isotretinoin FDA
2012-05-01 Actavis Totowa LLC Recalls Select Lots of Losartan Potassium Tablets, 50 mg Losartan FDA
2012-05-01 Teva Pharmaceuticals USA Recalls Single Lot of Mefloquine Tablets, 250mg Mefloquine FDA
2012-05-01 Quadrant Chemical Corporation Recalls Single Lot of DermaZinc Spray, (zinc pyritione) 0.25% Dermazinc FDA
2012-05-01 Apotex Inc. Recalls Single Lot of Cyclosporine Oral Solution, USP (modified), 100 mg/mL Cyclosporine FDA
2012-05-01 Schering-Plough Products Recalls Single Lot of Temodar (temozolomide capsules), 5 mg Temozolomide FDA
2012-05-01 Medtech Products, Inc. Recalls Several Lots of Pedia Care Infants Gas Relief Drops (Simethicone) Simethicone FDA
2012-05-01 Mylan Pharmaceuticals Inc. Recalls Several Lots of Morphine Sulfate ER Tablets, 200 mg Morphine FDA
2012-04-27 Recall of several lots of Good Neighbor Pharmacy, Night Time Liquid Caps Acetaminophen with Dextromethorphan and Doxylamine FDA
2012-04-27 Bayer Healthcare Recalls Select Lots of Alka-Seltzer Plus, Severe Sinus Congestion, Allergy & Cough Formula FDA
2012-04-27 Sandoz Incorporated Recalls Select Lots of Pramipexole Dihydrochloride Tablets, 0.125 mg Pramipexole FDA
2012-04-27 Updated information on drug interactions for Victrelis (boceprevir) Boceprevir FDA
2012-04-23 FDA Announces New Warning and Contraindications for Aliskiren-containing Medications Aliskiren FDA