Canada Reviewing Multaq Over Heart Worries

Add Canada to the list of countries taking a deeper look into prescription medication, <"">Multaq (dronedarone). Health Canada, said CTV News, is reviewing the drug’s safety.

Multaq is already approved to treat temporary Atrial Fibrillation (AF), or abnormal heart rhythm and was designed to be a safer alternative to amiodarone, a generic medicine with serious liver and lung risks only approved for life-threatening irregular beating in the heart’s lower chambers. Approximately 400,000 patients worldwide have been treated with Multaq since it came on the market in 2009. Sanofi was hoping to expand Multaq’s use to patients diagnosed with long-term AF; however, patients were experiencing increased cardiovascular events and hospitalizations on Multaq versus the placebo, said FiercePharma previously.

Multaq has been available in Europe since July 2009 and was approved in the United States since last year. Multaq is only approved in Canada for patients with certain types of intermittent AF, said CTV News.

The Multaq study, which was testing the drug as a treatment for permanent AF, was stopped on July 7th by Sanofi following its safety board’s recommendation. The Multaq clinical trial, known as the PALLAS study was halted early after a significant number of heart-related side effects were seen in the study. The trial, said CTV News, focused on patients over 65 years of age with permanent AF, as well as with other types of heart disease.

Following an announcement of an expanded European Medicines Agency (EMA) probe, the U.S. Food and Drug Administration (FDA), as expected, announced that it will be reviewing information from the Multaq clinical trial that was stopped over higher-than-expected adverse heart reactions in trial participants. The European review indicated significant cardiovascular reactions in some people.

Now, Health Canada will be reviewing Multaq data and the drug’s likelihood to increase problems such as stroke and heart attack and will take regulatory action, if needed, when its review is complete, said CTV News. “This 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,” its statement added.

In the U.S, the FDA is recommending that people taking Multaq speak with their physicians about the need to continue taking the drug, said Reuters previously. The FDA also issued a reminder to physicians not to prescribe Multaq for permanent AF.

The drug drew the attention of the EMA following reports of liver failure in two patients; the FDA then issued liver failure warnings in connection with Multaq, said Reuters. Sanofi and Health Canada also issued a warning this March over liver injury risks, said CTV News, advising patients on Multaq to report symptoms consistent with liver injury to their physicians. Symptoms include appetite loss, nausea, vomiting, unusual fatigue or darkening of the urine, pain or discomfort in the right upper stomach, yellowing of the skin or eyes, or itching, explained CTV News. Adverse reactions should be reported to Canada’s Canada Vigilance Program.

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