Multaq Heart Side Effects Under Review in Europe

Sanofi is facing an expansion of an ongoing review of its atrial fibrillation (AF) treatment, <"">Multaq (dronedarone). The European Medicines Agency (EMA) found that a study revealed possible heart risks in patients using the drug, said FiercePharma.

The Agency plans on reviewing data from the Multaq study, which was stopped by Sanofi last week following its safety board’s recommendation, explained FiercePharma. The Multaq clinical trial, known as the PALLAS study, was ended 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.

The drug 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 versus on Multaq versus the placebo, said FiercePharma.

Of note, 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.

The EMA had been watching Multaq; a safety review followed two cases of patients taking the drug suffering from liver failure, said FiercePharma. In January, the U.S. Food and Drug Administration (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.

The liver injuries prompted European regulators to launch safety reviews of Multaq. Late last month, France’s top medical regulator deemed Multaq “inadequate.” According to a prior FiercePharma report, that could result in the drug being removed from the state reimbursement formulary. Meanwhile, the EMA will have its experts review the current study and determine, when they meet next week, if additional action is needed.

In the interim, officials in France warned physicians to exercise care when prescribing Multaq: “Pending further information, [we recommend] doctors consider cardiovascular as well as liver risks before prescribing dronedarone,” quoted Dow Jones.

We previously wrote that Sanofi said that the PALLAS study was stopped after an independent safety monitor saw a “significant increase in cardiovascular events” in the group of patients taking Multaq. The company said it was notifying regulatory authorities in all countries where Multaq was approved. Sanofi said it provided the new trial information with international health regulators and is conducting an internal analysis. “Sanofi is cooperating fully with the European Medicines Agency on the review of Multaq,” it said in a statement.

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