FDA Requires Ischemic Event Warning be Added to Multaq Label


The U.S. Food and Drug Administration has ordered drug maker, Sanofi-Aventis, to update the label for its anti-arrhythmic medication, Multaq, in order to inform users of the increased risk for death or serious cardiovascular events when taken by patients with permanent atrial fibrillation. The FDA has approved Multaq (dronedarone) to treat atrial flutter and paroxysmal [...]