FDA Requires Ischemic Event Warning be Added to Multaq Label

The U.S. Food and Drug Administration has ordered drug maker, Sanofi-Aventis, to update the label for its anti-arrhythmic medication, Multaq, in order to inform users of the increased risk for death or serious cardiovascular events when taken by patients with permanent atrial fibrillation.

The FDA has approved Multaq (dronedarone) to treat atrial flutter and paroxysmal or persistent atrial fibrillation but not for permanent Afib. Sanofi-Aventis was in the process of testing Multaq in patients with permanent atrial fibrillation but the trial, known as PALLAS, was stopped before completion due to increased cardiovascular events in those taking the drug.

Data recently presented at a meeting of the American Heart Association confirmed that the use of Multaq come with an excessive risk, almost double that of the placebo, of cardiovascular events including stroke, myocardial infarction, systematic embolism and even death from cardiovascular problems.

The new label changes for the drug include the following:

Dronedarone should not be prescribed to patients with permanent atrial fibrillation (those who cannot or will not be converted into normal sinus rhythm) because of the twofold risk of cardiovascular death, stroke, and heart failure in such patients.

Patients on the drug should be monitored via ECG every three months and patients in atrial fibrillation should discontinue the drug or be cardioverted if that is clinically indicated.

Patients prescribed dronedarone should receive appropriate antithrombotic therapy.

(Source: Medpage Today News, FDA General Coverage)

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