FDA Investigates 2-Fold Death Increase in Multaq Trial

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The FDA is cautioning doctors to be wary of Multaq after it was associated with fatal heart problems in a recent study.

The Food and Drug Administration (FDA) is cautioning doctors to be wary of a heart drug from Sanofi which has been associated with fatal heart problems in a company study which was recently stopped.

According to an FDA report released on Thursday, Sanofi stopped a trial of its drug Multaq following the discovery that the trial participants taking Multaq were suffering twice as many heart attacks, strokes and deaths among patients in comparison with patients taking a placebo.

The study focused on patients over the age of sixty-five with atrial fibrillation. Of the 3,000 patients the trial was focusing on, thirty-two participants in the Multaq-group suffered cardiovascular deaths in comparison with fourteen deaths in the placebo group.

The FDA reported that federal health regulators are in the process of reviewing the trial data; they advised all patients currently taking Multaq to speak with their doctor.

In a statement, Sanofi reported that it still believes the drug to be helpful for patients suffering from atrial fibrillation.

"It is important that Multaq only be used in patients with non-permanent atrial fibrillation or atrial flutter, as per the current U.S. label," said a Sanofi spokesman.

The FDA approved Multaq in 2009 for the short-term form of atrial fibrillation and an associated condition, atrial flutter.

Among other recommendations stated in their most recent report, the FDA advised health care providers not to prescribe Multaq to patients with permanent atrial fibrillation.

According to the FDA report, roughly 241,000 United States patients were given a prescription for the twice-a-day pill as of last month.

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