HealthDay News — The FDA issued a warning that the heart drug dronedarone (Multaq),  should not be prescribed to patients with permanent atrial fibrillation because of an increased risk of serious cardiovascular events, including death.

The agency posted the announcement after reviewing the data from two clinical trials, one of which was terminated early due to a significantly higher number of cardiovascular events in the group taking dronedarone compared with the control group.

The drug’s label has been altered to reflect the following recommendations:

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  • Health care professionals should not prescribe the drug to patients who cannot or will not be converted into normal sinus rhythm (who are in permanent atrial fibrillation)
  • Because dronedarone doubles the rate of CV death, stroke and heart failure in these patients
  • Healthcare professionals should monitor cardiac rhythms at least once every three months in patients taking dronedarone and stop the drug (or cardiovert the patient) if atrial fibrillation is noted
  • Patients taking dronedarone should receive appropriate antithrombotic therapy

“[We are] providing new information and recommendations for the use of dronedarone to manage the potential serious cardiovascular risks with the drug,” the FDA wrote in a press release.

The FDA approved dronedarone to treat atrial flutter and paroxysmal or persistent atrial fibrillation based on 2009 data from the ATHENA trial, which indicated that the drug reduced rate of hospitalization from atrial fibrillation.