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Multaq (Dronedarone)
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Heart Woes Cause Sudden End to Multaq Trial

Jul 8, 2011 | Parker Waichman LLP

There is more  troubling news about  Multaq, Sanofi's drug for treating temporary atrial fibrillation, or abnormal heart beat.  Yesterday, the French drug maker announced it was ending  a Multaq study early after trial participants treated with the drug were found to have a higher occurrence of heart side effects.

It was just this past January that the U.S. Food & Drug Administration (FDA) 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.

Multaq has also been plagued by questions about its effectiveness.  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.

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. 

A statement issued by Sanofi yesterday said 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 has asked all PALLAS clinical investigators to inform their patients included in the trial to stop taking the study medication and consult their clinical trial center.

According to the statement, the benefit-risk profile of Multaq remains unchanged in its approved indication for temporary atrial fibrillation. Patients currently taking Multaq should not stop their therapy and should consult their treating physician should they have any questions, Sanofi said.


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