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FDA warns of 2-fold death increase seen with Sanofi heart drug Multaq
WASHINGTON (AP) ' Federal health regulators are warning doctors that a heart drug from Sanofi was associated with fatal heart problems in a recently halted company study.
The Food and Drug Administration reported Thursday that Sanofi halted a trial of its drug Multaq after patients taking the drug showed a two-fold increase in heart attacks, stroke and death compared with patients taking placebo.
The study enrolled patients with a permanent heart condition known as atrial fibrillation which causes the heart's chambers to pump irregularly. The FDA approved the drug in 2009 for a temporary form of the condition. About 241,000 U.S. have received a prescription for the drug.
The FDA said it is still reviewing the trial results and advises patients taking Multaq to talk with their doctor.