FDA puts new warnings on dronedarone

Reed Miller

December 19, 2011

Silver Spring, MD(corrected)- The FDA is requiring new safety warnings to be included on the labeling for the antiarrythmic drug dronedarone (Multaq, Sanofi-Aventis) in light of clinical data showing the drug increases the risk of serious cardiovascular events, including death, in patients with permanent atrial fibrillation (AF)[1].

The agency is adding the following revisions and recommendations to the drug's label: Healthcare professionals should prescribe the drug only to patients who can be converted into normal sinus rhythm, and the drug should be discontinued in patients in permanent AF. Healthcare professionals should monitor the heart rhythm of patients taking dronedarone by ECG at least once every three months.

Dronedarone is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of paroxysmal or persistent AF. Patients on dronedarone should also be on appropriate antithrombotic therapy, the FDA insists.

The FDA issued the new labeling after reviewing data from the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS) study. As reported by heartwire , PALLAS was a randomized trial of dronedarone in high-cardiovascular-risk patients with permanent atrial fibrillation that was stopped early when an interim analysis showed a significant increase in CV events in patients on the drug. The FDA also reviewed data from the pivotal ATHENA trial, which showed a 24% reduction in the primary end point of death or cardiovascular hospitalization over 21 months in lower-risk patients with recent paroxysmal or intermittent AF.

The FDA says it is still reviewing the risk evaluation and mitigation strategy for dronedarone and will determine what changes may be necessary to ensure that the benefits of the drug outweigh the risks.

As reported by heartwire , the European Medicines Agency (EMA) recently recommended that dronedarone "should only be prescribed after alternative treatment options have been considered."

An earlier version of this story incorrectly stated that dronedarone "should be discontinued in patients in AF."

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