The U.S. Food and Drug Administration (FDA) has completed a safety review of the heart drug Multaq (dronedarone). This review showed that Multaq increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF). The review was based on data from two clinical trials, the PALLAS trial (Permanent Atrial FibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy) and the ATHENA trial (which supported Multaq's approval for treatment of non-permanent AF).1,2 FDA is providing new information and recommendations for the use of Multaq to manage the potential serious cardiovascular risks with the drug.
The Multaq drug label has been revised with the following changes and recommendations [see the revised Multaq label2 for all changes]:
- Healthcare professionals should not prescribe Multaq to patients with AF 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 heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
- Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF (known as paroxysmal or persistent AF)
- Patients prescribed Multaq should receive appropriate antithrombotic therapy.
- Patients should contact their healthcare professional if they have any questions or concerns about Multaq.
Patients should not stop taking Multaq without talking to their healthcare professional.
FDA is reviewing the risk evaluation and mitigation strategy (REMS) for Multaq to determine the changes necessary to ensure that the benefits of Multaq outweigh the risks of cardiovascular death, stroke, and heart failure.
Data Summary
The PALLAS (Permanent Atrial FibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy) trial3 4was a large outcome trial intended to evaluate the effectiveness of Multaq in patients with permanent AF.1 This clinical trial was terminated early because of a significantly higher number of cardiovascular events in the Multaq-treated group compared to the group of patients given a placebo (i.e., with no active ingredient). FDA issued a Drug Safety Communication (DSC) in July 20115 when the study was terminated. ...more