Multaq Problems Lead to Cancellation of French Drug Reimbursements

Concerns over the potential side effects of Multaq, Sanofi-Aventis’s beleaguered heart drug, have led France to decide to no longer pay for the drug to be used by French citizens. 

Last week, France announced that it would no longer pay reimbursements to Multaq users, saying that the drug provided insufficient medical service. The move effectively kills the use of Multaq in France’s state-run health care market.

The French decision comes on the heels of the full release of data from a clinical trial known as PALLAS, which was a test by the manufacturer to see if Multaq could be used to treat permanent and recurring heart rhythm problems. However, the PALLAS trials were cancelled this summer due to an alarming number of heart attacks, strokes and deaths experienced by users, which has raised concerns over the possibility of Multaq heart problems.

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There have also been growing concerns over the risk of liver damage from Multaq. Earlier this year, the FDA warned that at least two Multaq patients suffered liver failure that required them to get organ transplants. There have been other reports of Multaq liver damage as well.

In September, the European Medical Association (EMA) decided to restrict Multaq to specific atrial fibrillation patients, and wants all of those patients regularly evaluated for potential Multaq problems.

In the United States, Multaq (dronedarone) was approved in July 2009 for the treatment of patients who have had abnormal heart rhythms in the last six months. In less than two years since its approval, there have been at least 492,000 Multaq prescriptions in the United States filled by about 147,000 patients at outpatient pharmacies across the country. In addition, the drug can be given to patients being treated in hospitals.


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