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The Associated Press December 19, 2011, 1:29PM ET

FDA adds new heart warning to Sanofi's Multaq

Federal health officials have added new safety warnings to the Sanofi drug Multaq after company studies linked the heart drug to higher rates of heart attack, stroke and death in a subset of patients.

The new label highlights two studies in which Multaq doubled the risk of heart-related complications in patients with permanent atrial fibrillation, a condition in which the heart's chambers pump out of sync. The label stresses that Multaq is only approved for the short-term form of the condition and a related ailment known as atrial flutter. Doctors routinely prescribe drugs for unapproved conditions.

The new label is the latest safety setback for Multaq, which Sanofi once touted as a potential blockbuster. Multaq already carries a warning that the drug should not be used by heart failure patients.

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