FDA reports increased risk of death in patients with permanent AF taking dronedarone, revises drug label

February 1, 2012

In mid-December, FDA reported that dronedarone (Multaq) increased the risk of serious cardiovascular events, including death, when used in patients with permanent atrial fibrillation (AF), according to its safety drug communication.

In mid-December, FDA reported that dronedarone (Multaq) increased the risk of serious cardiovascular events, including death, when used in patients with permanent atrial fibrillation (AF), according to its safety drug communication.

The review was based on data from 2 clinical trials, the PALLAS trial (Permanent Atrial FibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy) and the ATHENA trial, which supported the drug's approval for treatment of nonpermanent AF.

The drug label for dronedarone has been revised with a number of changes and recommendations.

ECG RECOMMENDED EVERY 3 MONTHS

In addition, healthcare providers should monitor cardiac rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, dronedarone must be stopped or, if clinically indicated, the patient should be cardioverted.

In addition, patients who are prescribed dronedarone should receive appropriate antithrombotic therapy.

Dronedarone was FDA approved in July 2009 and is indicated to reduce hospitalizations for AF in patients in sinus rhythm with a history of nonpermanent AF (known as paroxysmal or persistent AF).

FDA is also reviewing the Risk Evaluation and Mitigation Strategy for dronedarone to determine the changes needed to ensure that the benefits of the drug outweigh the cardiovascular risks.

FDA believes that dronedarone provides a benefit for patients with nonpermanent AF and recommends that healthcare professionals who prescribe the drug follow the recommendations in the revised dronedarone drug label.