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Dronedarone drug label revised to include risk for serious CV events
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The FDA completed a safety review of dronedarone, which showed that the heart drug increased the risk for serious CV events, including death, when used by patients with permanent atrial fibrillation. The review was based on data from the PALLAS and ATHENA trials. As a result of the review, the FDA has provided new information and recommendations for use of dronedarone to manage the potential serious CV events associated with the drug, according to a statement from the agency.
Changes to the dronedarone (Multaq, Sanofi) label are as follows:
- Health care professionals should not prescribe dronedarone to patients with AF who cannot or will not be converted into normal sinus rhythm because dronedarone doubles the rate of CVD, stroke and HF in such patients.
- Health care professionals should monitor heart rhythm by electrocardiogram 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.
- Dronedarone is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of paroxysmal or persistent AF.
- Patients prescribed dronedarone should receive appropriate antithrombotic therapy.
The agency is reviewing the risk evaluation and mitigation strategy (REMS) for dronedarone to determine the changes necessary to ensure that the benefits of dronedarone outweigh the risks for CVD, stroke and HF.
“The FDA believes that Multaq provides a benefit for patients with nonpermanent AF and recommends that health care professionals who prescribe Multaq follow the recommendations in the revised Multaq drug label,” according to a statement in the FDA press release.
In July 2011, the PALLAS trial was terminated early because of an increase in CV events among patients being treated with dronedarone vs. placebo. Results of the ATHENA trial showed a reduction in the risk for hospitalizations for AF in patients with nonpermanent AF who were taking dronedarone as well as no increased risk for CVD, stroke or HF.
It is estimated that 1.3 million prescriptions for dronedarone were dispersed from approval in July 2009 through October 2011.
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