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Multaq (Dronedarone)
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Multaq Heart Risks Prompt Canadian Review

Jul 26, 2011 | Parker Waichman LLP

Multaq, already under scrutiny in the U.S. and Europe because of a link to potentially serious heart side effects, is being reviewed by regulators in Canada.   As was the case elsewhere, the Health Canada Multaq review was prompted by the halt of a Multaq study because of a high number of severe heart-related problems among patients taking the drug.

Health Canada says it's evaluating information on Multaq and the potential for an increased risk of problems such as heart attack and stroke. It says it will take regulatory action as needed when the review is complete. That could include updating the labeling information with new safety information, the agency said.

"Health Canada will keep health professionals and the public informed of new safety recommendations coming out of the review as appropriate."

Multaq is approved to treat temporary atrial fibrillation. As we reported previously, the halted Multaq trial, called PALLAS, was evaluating the drug as a treatment for permanent atrial fibrillation.   Seventy percent of the 3,149 patients enrolled in PALLAS had permanent atrial fibrillation for over two year.   Those taking Multaq had double the risk of death, stroke, and heart failure hospitalizations.  There were 32 cardiovascular deaths in the Multaq group compared with 14 in the placebo group.

Adverse heart events are just the latest safety problems to be associated with Multaq.  In January, the U.S. Food & Drug Administration (FDA), Health Canada and regulators in Europe all warned that Multaq had been associated with severe liver injury.  When it was approved, the FDA also ordered that Multaq carry a black box warning stating the drug can cause life-threatening, severe complications in patients with recent severe heart failure.

According to the Los Angeles Times, cardiologists from the Cedars-Sinai Medical Center said last year that generic alternatives work better than Multaq and that the drug should be considered only when other alternatives don’t work.



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