Sanofi’s Multaq Causes Stroke or Even Death

(November 17, 2011) Paris-based Sanofi funded a study, which was published in the New England Journal of Medicine, showing there were 21 deaths from cardiovascular causes in the Multaq group compared with 10 deaths among those receiving placebo.

 

Sanofi’s Multaq was approved in 2009 to treat patients with intermittent racing of the heart.  However, studies have shown that in a trial of 3,236 patients, those given Multaq had a significant rise in stroke and heart failure rates. Doctor’s had hoped Multaq’s ability to reduce deaths, strokes, and hospitalizations in patients with occasional atrial fibrillation would also help those with more serious forms of the condition.  These study findings contradict those hopes.  Stuart Connolly, from the Population Health Research Institute in Hamilton, Ontario said, “We have had a healthy suspicion of anti-arrhythmic drugs for many years, but we had thought this drug didn’t have the same risks.”  “We are now getting the message that this drug has the potential to harm as well,” he said. “It seems this drug acts very differently depending on which type of patient receives it.”

 

The U.S. Food and Drug Administration are reviewing Multaq’s safety profile.

 

It was recently decided by France’s top medical authority, the Haute Autorite de Sante, that Multaq should be withdrawn from the list of drugs reimbursed by the state-run health system.  HAS said in July that Multaq, known chemically as dronedarone, was not sufficiently effective.  As of December 1, 2011 France will stop reimbursement of Multaq, Sanofi’s irregular heart beat drug, according to a notice published in the government’s official bulletin. A Sanofi sppkesman said the company disagrees with the decision, stating that France is the only country in Europe who has decided to stop reimbursement of Multaq.  Europe’s drug regulator restricted the use of Multaq in September stating that the drug should only be prescribed after all alternative treatments have been considered.

 

In July, EU and US regulators widened their review into whether or not Multaq causes cardiovascular disease.  This came after a probe into a possible link between Multaq and liver failure.  This more involved review was prompted by Sanofi’s decision to stop a late-study clinical trial of Multaq when it noticed a “significant” rise in cardiovascular side effects such as heart attacks and strokes.

 

Before these involved studies, analysts predicted Multaq’s potential annual sales to exceed $1 billion.

 

It would seem to me to stick with the rapid heart beats as opposed to taking a drug that causes heart attack, stroke or possibly even death. Feel free to comment on this blogpost.

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