FDA Approves Dronedarone (Multaq) For Atrial Fibrillation

As expected, this week the United States Food and Drug Administration (FDA) approved dronedarone (Multaq, Sanofi-Aventis) for the treatment of atrial fibrillation. Dronedarone is thought to be a safer alternative for atrial fibrillation than its close cousin, amiodarone. The approval of the new drug largely rested on the results of the ATHENA trial, which demonstrated a significant reduction in the composite endpoint of death or hospitalization when dronedarone was compared to placebo.

There are some lingering questions with dronedarone, however. In another clinical trial, patients with significant heart failure actually had significantly increased mortality when this drug was used.

Accordingly, the new FDA indication for dronedarone specifies that the drug should be avoided in patients with significant heart failure.

You can read more about dronedarone here.