Multaq Maker Issues Formal Alert for Halted Study

Sanofi-Aventis has formally alerted doctors that a clinical trial involving <"">Multaq (dronedarone) was halted because patients in the study’s Multaq group were dying at more than twice the rate of that of patients taking placebo. “Healthcare professionals are advised to monitor patients regularly (at least every six months) in order to ensure that they remain within the approved indication and do not progress to permanent atrial fibrillation or new or worsening heart failure,” the letter warns.

The trial in question, called PALLAS (Permanent-Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy), was halted on July 7. PALLAS was testing Multaq in patients over 65 years of age with permanent atrial fibrillation and at least one other cardiovascular disease risk fact.

The halting of the PALLAS study prompted the European Medicines Agency to expand a Multaq safety review it had launched in January, after the drug was associated with reports of liver failure. The U.S. Food & Drug Administration (FDA) also decided to review Multaq for heart risks after being informed that PALLAS was halted. The FDA has advised that people taking Multaq speak with their physicians about the need to continue taking the drug, and it has reminded doctors not to prescribed Multaq to people with permanent atrial fibrillation.

Multaq, approved to treat temporary atrial fibrillation, was designed to be a safer alternative to amiodarone, a generic medicine with serious liver and lung risks that is 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.

In January, the FDA announced that the U.S. label for Multaq had been 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 had been reported among Multaq patients. The FDA suggested that health care providers consider having patients undergo periodic liver enzyme tests, especially in the first six months of treatment with Multaq.

Multaq has been the subject of other concerns since coming on the market, particularly regarding its effectiveness. For example, 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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