FDA Adds Risk for Death and Serious Cardiovascular Events to Multaq Label

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.

Sanofi was testing Multaq in patients with permanent atrial fibrillation in the PALLAS trial, but the study was stopped early due to increased cardiovascular events in patients taking Multaq. Data just presented at the 2011 American Heart Association meeting has now confirmed the increased risk – which is almost double that seen in placebo-treated patients – for stroke, myocardial infarction, systemic embolism or death from cardiovascular causes.

Multaq is also associated with liver damage, as reported in two post-marketing case reports of acute liver failure requiring transplantation. The FDA alerted healthcare professionals to this risk in January 2011, and recommends patients undergo periodic liver enzyme tests while taking the drug, especially during the first six months of treatment.

FDA Adds Risk for Death and Serious Cardiovascular Events to Multaq Label

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