December 21, 2011 - This week, the U.S. Food & Drug Administration (FDA) issued a safety warning for Sanofi’s popular heart drug Multaq (dronedarone), indicating that it may double the risk of death, stroke and heart problems in patients with permanent atrial fibrillation.

The administration has completed a safety review of Multaq, and is making new label changes to recommend that it not be used in patients with permanent abnormal heart rhythms.

The results of the safety review are now being considered to determine whether the benefits of Multaq outweigh the potential risks of heart failure, stroke, and cardiovascular death. If the administration finds that the risks are greater than the potential rewards, a nationwide Multaq recall may be issued in the near future.

Patients taking Multaq have been advised to have their heart rhythms checked at least once every three months. If the individual is in atrial fibrillation, Multaq regimens should be discontinued or, if possible, they should be cardioverted.

FDA’s decision came in response to the results of a clinical trial known as PALLAS, which was a test conducted by Sanofi to determine whether Multaq could be used to treat chronic heart rhythm problems. However, the PALLAS trials were cancelled earlier this year due to a high number of heart attacks, strokes, and deaths experienced by Multaq users.

Making matters worse for Multaq, there have also been reports of severe liver damage and liver failure associated with the drug. Earlier this year, the FDA issued a press release stating that at least two former Multaq users had suffered liver failure that required them to get organ transplants.

First approved in July 2009, Multaq is prescribed for the treatment of patients who have had prolonged abnormal heart rhythms. In its short time on the market, Multaq has been prescribed nearly a half million times to approximately 150,000 individuals in outpatient pharmacies around the country. Multaq has also been indicated for use in patients being treated in hospitals.