Product Liability

Study of heart drug Multaq canceled due to two-fold risk of death

A clinical trial evaluating the effects of antiarrhythemic drug Multaq (Dronedarone) in patients with permanent atrial fibrillation was stopped prematurely after data showed a two-fold increase in death, as well as two-fold increases in stroke and hospitalization for heart failure in patients receiving the drug compare to patients taking a placebo.

Multaq is currently approved by the Food and Drug Administration (FDA) for use in a different, but related, condition. It is used to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation or atrial flutter, with a recent episode of these conditions and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted. The approval of the drug for these conditions was based on data that showed use of Multaq in this manner decreased the number of deaths compared to placebo.

The Permanent Atrial fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS) study, sponsored by Sanofi Aventis, the maker of Multaq, was conducted to assess the potential clinical benefit of the drug in patients over 65 years of age with permanent atrial fibrillation.

One critical question that remains is whether and how the unfavorable results of the study, obtained in patients with permanent atrial fibrillation, may apply to patients who use the drug for indications that are already approved by the FDA.

The FDA previously issued a Drug Safety Communication on Multaq warning of the risk for a rare but serious liver injury.

At this time, patients taking Multaq should talk to their doctors about whether they should continue taking Multaq. Patients should not stop the medication without first discussing the risks and benefits of discontinuing with their doctors.

Any side effects with this or any other drug should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/report.htm.

Source: FDA