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A drug used successfully to reduce the risk of death, stroke, and hospitalization for patients with occasional atrial fibrillation has been found to double the risk of death for those with a permanent form of the erratic rhythm. Sanofi’s Multaq is approved for the treatment of patients whose hearts intermittently race with quick and inefficient contractions. Sanofi had hoped that a study of 3,236 patients would prove that Multaq would also have success in patients with a more serious form of the condition. That study was halted in July because of the increased danger of stroke and heart failure.

The recent study was designed to evaluate effectiveness of Multaq in patients suffering from a permanent form of atrial fibrillation. Among patients receiving Multaq, there were 21 deaths from cardiovascular causes. In the placebo group, there were ten such deaths.

Approved in 2009, Multaq was hailed by the company as a $1 billion-plus blockbuster drug prior to its launch. Analysts now believe this drug will be lucky to hit $680 million in sales by 2015 as a result of the recent string of bad news. In addition to the halting of this study, The European Medicines Agency’s Committee for Medicinal Products for Human Use (CMHP) recommended on September 23, 2011 that the use of Multaq be restricted due to an increased risk of liver and lung injury.

The FDA is reviewing Multaq’s safety profile.

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