Multaq-Associated Cardiovascular Events Stops Clinical Trial Early Legal News Articles & Interviews

Washington, DC The Food and Drug Administration (FDA) has revised the labeling for Multaq (Dronedarone) to include the increased risk for death and serious cardiovascular events when the drug is taken by patients with permanent atrial fibrillation. Multaq, made by Sanofi-Aventis, is indicated for treatment of atrial flutter and paroxysmal or persistent atrial fibrillation, but not permanent atrial fibrillation.

Paris, France Sanofi's heart-rhythm drug Multaq, has been given a new indication by the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), essentially limiting the drug's use for safety reasons. The Food and Drug Administration (FDA) is expected to take similar steps shortly. Multaq, also know as dronedarone, has been associated with an increased risk of liver, lung, and cardiovascular adverse events.

Washington, DC A clinical trial designed to assess the effectiveness of a drug to treat abnormal heart rate has been stopped early following a discovery by a data-monitoring committee of a two-fold increase in death, according to a communiqué from the US food and Drug Administration (FDA). The drug agency is reviewing the data from Multaq, manufactured by Sanofi Aventis—as is Health Canada north of the border.