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FDA Completes Study Reviewing Efficacy and Safety of Pradaxa® (dabigatran)
The U.S. Food and Drug Administration (FDA) has recently completed a new study comparing the blood thinner Pradaxa® (dabigatran) to the blood thinner warfarin (Coumadin®, Jantoven®, and generics) in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation (AF). This study is part of the FDA’s ongoing review of the efficacy and safety of Pradaxa®. It was conducted to better understand the risk of stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, heart attack, and death when either of these medicines are taken by patients with non-valvular AF who are 65 years or older. The study included more than 134,000 Medicare patients and found that Pradaxa® was associated with: - a lower risk of stroke, bleeding in the brain, and death compared with warfarin - an increased risk of major GI bleeding compared with warfarin - a similar risk for heart attack compared with warfarin This study’s findings, except with regard to heart attacks, are similar to the clinical study results that supported the FDA’s approval of Pradaxa®. The FDA will continue to review anticoagulant use and the risk of bleeding and will update the public with any relevant information that becomes available. For more information, please visit:
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FDA Issues Drug Safety Communication about the Risk of Seizures with Ampyra (Dalfampridine)
The U.S. Food and Drug Administration (FDA) is updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis (MS) who are starting Ampyra (dalfampridine). Using information received from post-market adverse event reports, FDA recently evaluated seizure risk in MS patients taking Ampyra (dalfampridine). The majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures. Seizures are a known side effect of Ampyra, and seizure risk increases with higher blood levels of the drug. Ampyra is eliminated from the body through the kidneys, and patients with kidney impairment may develop higher blood levels of the drug, thereby increasing their seizure risk. The FDA is also updating the Ampyra prescribing information to clarify recommendations that kidney function should be checked in patients before starting Ampyra and monitored at least annually while Ampyra treatment continues. Additionally, patients who miss a dose should not take extra doses — an extra dose of Ampyra can increase seizure risk. Ampyra contains the active ingredient dalfampridine and is used to improve walking in patients with MS. For more information, please visit:
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Date Published Title Drug Source
2014-05-14 FDA Completes Study Reviewing Efficacy and Safety of Pradaxa® (dabigatran) Dabigatran FDA
2012-07-23 FDA Issues Drug Safety Communication about the Risk of Seizures with Ampyra (Dalfampridine) Dalfampridine FDA
2010-07-29 FDA Warns about Risk of Developing Rare Type of Pneumonia During Treatment With Cubicin Daptomycin FDA
2007-11-09 Strengthened box warning for cancer and chronic kidney failure Darbepoetin Alfa FDA
2008-01-03 FDA Communication Regarding New Anemia Drug Studies Darbepoetin Alfa FDA
2008-08-01 FDA Recommends Limits on Use of Erythropoiesis Stimulating Agents in Cancer Patients Darbepoetin Alfa FDA
2009-08-27 Two Recent Studies Support Safety Concerns of Erythropoiesis Stimulating Agent Use in Cancer Patient Darbepoetin Alfa MediGuard CRT
2011-08-16 Novartis Pharmaceuticals Recalls Single Lot of Enablex Darifenacin FDA
2011-10-11 Sprycel Linked To Raised Blood Pressure In The Lungs Dasatinib FDA
2009-09-28 FDA Early Communication About Ongoing Safety Review of Exjade Deferasirox FDA
2010-02-18 Boxed Warning and Other Changes to the EXJADE Prescribing Information Deferasirox Manufacturer
2012-05-01 Quadrant Chemical Corporation Recalls Single Lot of DermaZinc Spray, (zinc pyritione) 0.25% Dermazinc FDA
2012-07-22 Dermallogix Partners Recalls Single Lot of DermaZinc Spray, 0.25% zinc pyritione Dermazinc FDA
2009-12-03 Changes to the Warnings Sections of Norpramin (desipramine) Prescribing Information Desipramine FDA
2007-12-04 Revised prescribing information regarding severe hyponatremia and seizures Desmopressin FDA
2011-09-16 Qualitest Pharmaceuticals Recalls Birth Control Pills Due To Packaging Error that May Increase Risk of Unintended Pregnancies Desogestrel with Ethinylestradiol Manufacturer
2013-01-02 Watson Pharma Recalls Select Lots of Caziant (Desogestrel and Ethinyl Estradiol) Tablets Desogestrel with Ethinylestradiol FDA
2009-01-12 New Antidepressant Guide for Patients Desvenlafaxine FDA
2008-08-04 Generic Manufacturer Recalls Several Drug Products Manufacturer
2010-03-05 FDA Approves Name Change for Heartburn Drug Kapidex Dexlansoprazole FDA
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