FDA, EU Review Sanofi Heart Drug After Failed Trial

Law360, New York (July 22, 2011, 2:56 PM EDT) -- American and European regulators said Thursday that they were reviewing the safety of Sanofi-Aventis SA's heart drug Multaq after the company halted a clinical trial in which users of Multaq were twice as likely to die as a control group.

Sanofi-Aventis stopped the trial earlier in July when data showed that Multaq doubled the risk of stroke, heart failure and death among participants taking the drug. The U.S. Food and Drug Administration is investigating whether patients with nonpermanent atrial fibrillation, for whom Multaq is approved, face...
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