Multaq Patients Had Double Death Risk in Halted Trial

A study has found that patients taking <"http://www.yourlawyer.com/topics/overview/multaq-dronedarone-liver-damage-failure-lawsuit-lawyer-attorney">Multaq to control serious, permanent atrial fibrillation, may face a doubled risk of death. Such Multaq patients also face a much higher risk of suffering a heart attack and stroke, according to the study.

According to a report from Bloomberg News, the findings come from a Multaq trial of 3,236 patients that was halted in July because of the increased risk of death, heart attack and stroke. The trial, known as PALLAS, was a blow to Sanofi, the maker of the drug, and health care practitioners who had hoped Multaq would be a safe alternative to ather atrial fibrillation drugs.

“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,” lead researcher Stuart Connolly, from the Population Health Research Institute in Hamilton, Ontario, told Bloomberg in a telephone interview. “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 Multaq study, which was funded by Sanofi and published in the New England Journal of Medicine, was presented yesterday at the American Heart Association’s annual meeting in Orlando, Florida. According to Bloomberg, 21 Multaq patients died during the trial, compared to 10 among those getting placebo.

The U.S. Food and Drug Administration (FDA) is currently conducting a review of the safety of Multaq, but has not yet reached a decision regarding possible restrictions on the drug. In January, the FDA announced that the U.S. label for Multaq had been updated, following reports of liver damage, including severe liver failure, associated with the drug. The halt of the PALLAS study prompted the FDA to announce in July that it was expanding its review of Multaq, and the agency recommended that people taking Multaq speak with their physicians about the need to continue taking it. The FDA also reminded physicians that Multaq should not be prescribed to people with permanent atrial fibrillation.

In September, a committee of the European Medicines Agency (EMA) said Multaq shouldn’t be used in most people with permanent atrial fibrillation, but left it on the market for some patients with a more intermittent form of the disease. However, the agency also cautioned doctors to consider other atrial fibrillation treatments before they prescribe Multaq.

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