News from the FDA

The Food and Drug Administration has approved dronedarone to help maintain normal heart rhythms in outpatients with a history of atrial fibrillation or atrial flutter. The agency approved the drug with the stipulation that its manufacturer, Sanofi-Aventis, launch a Risk Evaluation and Mitigation Strategy aimed at educating health care providers about who should receive the agent. Appropriate patients include those “whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heartbeat,” according to a statement from the FDA. Dronedarone is contraindicated in patients with severe heart failure.