FDA Drug Safety Communication

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FDA Date: 12/19/11

Multaq FDA Drug Safety Communication

Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events

FDA has completed a safety review of the heart drug Multaq (dronedarone). This review showed that Multaq increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF). The review was based on data from two clinical trials, the PALLAS trial (Permanent Atrial FibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy) and the ATHENA trial (which supported Multaq's approval for treatment of nonpermanent AF). FDA is providing new information and recommendations for the use of Multaq to manage the potential serious cardiovascular risks with the drug.

The Multaq drug label has been revised with the following changes and recommendations [see the revised Multaq label for all changes]:

- Healthcare professionals should not prescribe Multaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.

- Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.

- Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of nonpermanent AF (known as paroxysmal or persistent AF)

- Patients prescribed Multaq should receive appropriate antithrombotic therapy.

Patients should contact their healthcare professional if they have any questions or concerns about Multaq. Patients should not stop taking Multaq without talking to their healthcare professional.

FDA is reviewing the risk evaluation and mitigation strategy (REMS) for Multaq to determine the changes necessary to ensure that the benefits of Multaq outweigh the risks of cardiovascular death, stroke, and heart failure.

View the full FDA Drug Safety Communication on FDA.gov