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FDA Issues Alerts on Sanofi (France) (SASY.PA)'s Heart Drug Multaq


7/22/2011 6:56:10 AM

American and European regulators issued safety alerts on Thursday about Multaq, a drug approved two years ago to treat abnormal heart rhythms. The Food and Drug Administration said a study of the drug in patients with a long-term form of the disease, known as atrial fibrillation, showed twice as many deaths as those who did not take the drug. The alerts provided the first details of a 3,000-patient trial halted by Sanofi-Aventis two weeks ago. The company had cited “a significant increase in cardiovascular events.” Multaq was approved for short-term arrhythmia lasting less than six months. Since then, the F.D.A. said, 241,000 Americans have received prescriptions.

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