New Multaq Alert Issued by FDA

Following 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 a <"">Multaq clinical trial that was stopped over higher-than-expected adverse heart reactions in trial participants.

Last week, the EMA widened its investigation into Sanofi’s atrial fibrillation (AF) treatment, Multaq (dronedarone). The European review indicated significant cardiovascular reactions in some people, said Reuters.

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

The Multaq study 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, which was testing Multaq as a treatment for permanent AF.

Multaq is already approved to treat temporary AF, or abnormal heart rhythm. Multaq 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.

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.

In January, the FDA announced that the U.S. label for Multaq was updated following reports of liver damage, including severe liver failure, associated with the drug. According to an FDA alert issued at the time, two cases of severe liver failure requiring transplantation were reported in Multaq patients. The FDA suggested health care providers consider having patients undergo periodic liver enzyme tests, especially in the first six months of treatment with Multaq.

Since, the European agency expanded its review of Multaq to include an assessment of the results of the clinical trial to make a decision if any additional action was called for. That decision was expected this week, said Reuters. That deadline was just extended by the agency until September.

Late last month, France’s top medical regulator deemed Multaq “inadequate.”

According to a prior Los Angeles Times report, 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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