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The FDA Warns About Possible Risk of Severe Liver Injury with Dronedarone (Multaq)
The Food and Drug Administration (FDA) notified healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication dronedarone (Multaq). Information about the potential risk of liver injury from dronedarone (Multaq) is being added to the Warnings and Precautions and Adverse Reactions sections of the dronedarone (Multaq) prescribing information. Dronedarone is sold under the brand name Multaq and is a drug used to treat patients who have had an abnormal heart rhythm during the past six months. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm240011.htm
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FDA Reviewing Results of Study Multaq (Dronedarone) in Patients with Permanent Atrial Fibrillation
Severe side effects have been detected in a large clinical study of the drug Multaq (dronedarone). This led the manufacturer Sanofi Aventis to the stop the study early. In the study called Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS), dronedarone was given to patients with permanent atrial fibrillation, an abnormal rhythm of the heart. Patients who received the drug had a higher risk for severe cardiovascular events including stroke and heart attack than patients who received placebo. Currently Multaq is only approved for use in patients with non-permanent atrial fibrillation (also known as paroxysmal or persistent atrial fibrillation), a different, but related patient population of the PALLAS study. The U.S. Food and Drug Administration (FDA) is reviewing the results of the PALLAS study to determine whether and how the results of the PALLAS study, apply to patients who use Multaq for the approved indications (non-permanent atrial fibrillation). For more information please visit: http://www.fda.gov/Drugs/DrugSafety/ucm264059.htm
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Date Published Title Drug Source
2011-01-16 The FDA Warns About Possible Risk of Severe Liver Injury with Dronedarone (Multaq) Dronedarone FDA
2011-07-22 FDA Reviewing Results of Study Multaq (Dronedarone) in Patients with Permanent Atrial Fibrillation Dronedarone FDA
2011-12-19 FDA Completes Safety Review of Multaq and Updates Prescribing Information Dronedarone FDA
2009-12-18 Recall of Several Lots of Yaz and Ocella Drospirenone with Ethinyl Estradiol FDA
2011-04-25 Clot Risk May Be Higher With Newer Birth Control Pills Drospirenone with Ethinyl Estradiol MediGuard CRT
2011-05-31 FDA to review studies showing higher blood clot risk from drospirenone Drospirenone with Ethinyl Estradiol FDA
2011-09-26 The FDA Continues to Be Concerned about the Increase Risk of Blood Clots with YAZ (generics – Gianvi and Loryna), Yasmin (generics – Ocella, Syeda, and Zarah), Beyaz, and Safyral Drospirenone with Ethinyl Estradiol FDA
2011-10-27 FDA Continues Review of the Risk of Blood Clots in Women Taking Birth Control Pills Containing Drospirenone Drospirenone with Ethinyl Estradiol FDA
2012-04-11 FDA Completes Safety Review of Drospirenone-Containing Birth Control Pills - Yaz (generics – Gianvi and Loryna), Yasmin (generics – Ocella, Syeda, and Zarah), Beyaz, and Safyral Drospirenone with Ethinyl Estradiol FDA
2011-10-25 FDA: Xigris [drotrecogin alfa (activated)] Withdrawn From Market Due to Failure to Show Benefit FDA
2009-01-12 New Antidepressant Guide for Patients Duloxetine FDA
2008-08-21 Drug Shortage Manufacturer
2008-10-03 First Reported Case of Progressive Multifocal Leukoencephalopathy (PML) in a Raptiva Patient Efalizumab Manufacturer
2008-10-17 Raptiva (Efalizumab) Boxed Warning Efalizumab FDA
2009-02-19 Updated Safety Information Efalizumab FDA
2009-04-09 Withdrawal of Raptiva (efalizumab) From the U.S. Market Efalizumab Manufacturer
2008-08-12 Angioedema and ACE inhibitors Enalapril MediGuard CRT
2012-10-02 Apace KY LLC Recalls Single Lot of Enalapril 5mg Tablets Enalapril FDA
2008-08-12 Angioedema and ACE inhibitors Enalapril Maleate with Hydrochlorothiazide MediGuard CRT
2010-03-31 The FDA Issues Drug Safety Communication: Ongoing Safety Review of Stalevo and Possible Development of Prostate Cancer Entacapone FDA
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