FDA adds new warnings to dronedarone

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The US Food and Drug Administration (FDA) has added new changes and recommendations to dronedarone (Multaq, Sanofi Aventis) labeling, after finding that the anti-arrhythmic drug increases the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF).

The FDA’s review was based on data from the PALLAS trial in which the number of deaths taking dronedarone doubled the number of deaths taking placebo. Furthermore, the combined endpoint of cardiovascular death, myocardial infarction, stroke and system embolism was significantly increased in the active treatment arm (2% vs. 0.9; p=0.009), as reported by Cardiac Rhythm News in June 2011.


In September 2011, the European Medicines Agency also recommended restricting use of dronedarone in the European Union, based on the results of the PALLAS trial. The Agency stated that dronedarone “should only be prescribed for maintaining heart rhythm in patients with paroxysmal or persistent atrial fibrillation for the maintenance of sinus rhythm after successful cardioversion.” It also said the drug should only be used after other treatments for atrial fibrillation have been considered.


FDA’s changes and recommendations:

  • Healthcare professionals should not prescribe dronedarone to patients with atrial fibrillation 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 cardiac rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, dronedarone should be stopped or, if clinically indicated, the patient should be cardioverted.
  • Multaq is indicated to reduce hospitalisation for AF in patients in sinus rhythm with a history of paroxysmal or persistent AF.
  • Patients prescribed Multaq should receive appropriate antithrombotic therapy.

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