FDA Requires Ischemic Event Warning be Added to Multaq Label

multaq

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 [...]

Multaq (Dronedarone) Deemed Dangerous in Permanent Atrial Fibrillation

multaq

New research suggests that the use of dronedarone (Multaq) could be dangerous in permanent atrial fibrillation cases due to cardiovascular and mortality risks. The analysis of data collected during the now halted PALLAS trial revealed a “2.29-fold excess in stroke, myocardial infarction, systemic embolism and death from cardiovascular causes combined among patients taking the rhythm [...]

Multaq Makes Fifth Appearance on FDA Watch List

multaq

Each quarter, the U.S. Food and Drug Administration releases an updated list of drugs to watch for potential signs of serious side effects or safety issues. For the fifth consecutive time, Sanofi-Aventis’ Multaq (dronedarone) is included. The FDA’s most recent watch list covers the first three months of 2011. During this span of time, the [...]