FDA Tightens Restrictions On Sanofi's Multaq

Law360, Washington (December 19, 2011, 6:16 PM EST) -- The U.S. Food and Drug Administration on Monday revised its label for Sanofi SA's heart rhythm drug Multaq, saying a safety review showed the drug could increase the risk of death in some patients.

The FDA, joined by European regulators, said in July that it was reviewing the safety of Multaq after the company halted a clinical trial in which users of Multaq were twice as likely to die as a control group.

“Multaq increased the risk of serious cardiovascular events, including death, when used by...
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