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Study Finds Multaq Doubles Heart Disease Death Risk

Nov 15, 2011 | Parker Waichman LLP

A new study has revealed a connection between Multaq (dronedarone), approved to treat temporary atrial fibrillation, and a two-fold risk of death in those who suffer from permanent erratic cardiac rhythm.

The study found that, in addition to the death risk, stroke and heart failure incidences also significantly rose in patients who took Sanofi-Aventis’ Multaq during a clinical trial involving 3,236 patients, wrote Bloomberg Businessweek. The research was halted this July over the increased risks; results were just presented at the American Heart Association’s annual meeting in Florida.

Physicians had hoped that the benefits seen in Multaq patients suffering from temporary atrial fibrillation would be seen in patients suffering from the more serious permanent erratic rhythm, noted Businessweek, citing the study’s lead researcher Stuart Connolly, from the Population Health Research Institute in Hamilton, Ontario.

“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,” Connolly said in a telephone interview with Businessweek. “We are now getting the message that this drug has the potential to harm as well…. It seems this drug acts very differently depending on which type of patient receives it,” added Connolly. The study appears in the New England Journal of Medicine.

The trial resulted in 21 deaths from cardiovascular causes in the group taking Multaq, versus 10 deaths in the placebo group, said Businessweek.

While the results do not affect Multaq’s use for intermittent atrial fibrillation, said Deepak Bhatt, chief of cardiology at the VA Boston Healthcare system and director of the interventional cardiovascular program at Brigham and Women’s Hospital in Boston, the research will now look at Multaq’s off-label use, said Businessweek. “Often doctors are doing things based on a hunch or an anecdote,” Bhatt told Businessweek in a telephone interview. “In the right patient, this drug can be useful, but the broader use in high-risk patients, that clearly isn’t going to happen,” he noted.

Use of Multaq has been restricted by regulators in Europe and a committee of the European Medicines Agency (EMA) said Multaq shouldn’t be used in most people with permanent atrial fibrillation. The EMA did allow Multaq’s use for patients with intermittent atrial fibrillation; however, the EMA did warn physicians to consider other treatments before Multaq.

The EMA’s Multaq recommendations were based on a review of the PALLAS trial and other data that pointed to increased liver and lung injury in patients taking Multaq. Meanwhile,  the U.S. Food and Drug Administration (FDA) is reviewing Multaq’s safety and, in January, announced that Multaq’s U.S. label was updated following reports of liver damage, including severe liver failure. After the PALLAS trial was halted, the FDA expanded the scope of its review also reminded physicians that Multaq should not be prescribed to people with permanent atrial fibrillation.

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