The U.S. Food and Drug Administration has ordered drug maker, Sanofi-Aventis, to revise the label of its anti arrhythmic medication, Multaq (dronedarone), in order to more accurately reflect its increased risk of death or serious cardiovascular events when taken by patients experiencing permanent atrial fibrillation. Multaq has been approved by the FDA to treat atrial flutter and paroxysmal or persistent atrial fibrillation, but not permanent Afib.

Data presented at a recent meeting of the American Heart Association confirmed the excessive risk for cardiovascular events including stroke, myocardial infarction, systemic embolism and even death associated with the use of Multaq.

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)

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