FDA Drug Safety Communication

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FDA Date: 7/21/11

Multaq (dronedarone) FDA Drug Safety Communication

Multaq (dronedarone) and Increased Risk of Death and Serious Cardiovascular Adverse Events

FDA is reviewing data from a clinical trial that was evaluating the effects of the antiarrhythmic drug Multaq (dronedarone) in patients with permanent atrial fibrillation. The study was stopped early after the data monitoring committee found a two-fold increase in death, as well as two-fold increases in stroke and hospitalization for heart failure in patients receiving Multaq compared to patients taking a placebo. Currently Multaq is approved for use in a different, but related patient population. The approval of Multaq was based on another trial (ATHENA) in which use of Multaq was associated with a decreased number of deaths compared to placebo.

The Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS) study, sponsored by Sanofi Aventis (the maker of Multaq), was being conducted to assess the potential clinical benefit of Multaq in patients >65 years of age with permanent atrial fibrillation in the reduction of:

-Major cardiovascular (CV) events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death), or

-Unplanned cardiovascular hospitalization or death from any cause

A critical question is whether and how the unfavorable results of the PALLAS study, obtained in patients with permanent atrial fibrillation, apply to patients who use Multaq for the approved indications (non-permanent atrial fibrillation, also known as paroxysmal or persistent atrial fibrillation).

At this time, patients taking Multaq should talk to their healthcare professional about whether they should continue to take Multaq for non-permanent atrial fibrillation. Patients should not stop taking Multaq without talking to a healthcare professional. Healthcare professionals should not prescribe Multaq to patients with permanent atrial fibrillation.

FDA previously issued a Drug Safety Communication in January 2011 regarding cases of rare but severe liver injury that have been reported with the use of Multaq. Today's communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. FDA will update the public when more information is available.

View the full FDA Drug Safety Communication on FDA.gov