December 20, 2011 – The U.S. Food and Drug Administration (FDA) completed a safety review of the anti-arrhythmia drug Multaq (dronedarone). It showed an increased 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, PALLAS and ATHENA. 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:
- 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 three 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 non-permanent AF (known as paroxysmal or persistent AF)
- Patients prescribed Multaq should receive appropriate antithrombotic therapy.
For more information: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm264204.htm
August 20, 2025 
