The drug Multaq, also known as dronedarone, which is used to treat abnormal heart rhythms, appears to double the risk of premature death in patients with a long-term form of atrial fibrillation, according to early results of a major clinical trial, the U.S. Food and Drug Administration said yesterday.
Patients 65 and older with the condition who took Multaq also faced a higher risk of stroke and hospitalizations for heart failure. It’s still unclear whether the drug poses similar risks to patients with other forms of atrial fibrillation.
The FDA said patients taking Multaq should not stop taking the drug but should contact their doctor or other health-care professional. The agency also said doctors should not prescribe Multaq to patients with permanent atrial fibrillation.
About 241,000 patients filled prescriptions for Multaq between July 2009 and June 2011, according to the FDA. And the New York Times reports that last year Sanofi-Aventis, the maker of the drug, collected some $246 million in sales of the drug.
Multaq and increased risk of death and serious cardiovascular adverse events [FDA]
FDA issues alerts on the heart drug Multaq [New York Times]