Safety Alerts & Recalls
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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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