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EMA reviews Multaq's CVD risk

The European Medicines Agency is to review the cardiovascular risk of Sanofi's anti-arrhythmic medicine Multaq following serious adverse events in the company's discontinued PALLAS study

The European Medicines Agency (EMA) is to review the cardiovascular risk of Sanofi's anti-arrhythmic medicine Multaq (dronedarone) following serious adverse events in the company's discontinued PALLAS study.

Results from the study, which investigated the effects of Multaq in more than 3,149 patients over 65 years of age with permanent atrial fibrillation, found a higher rate of events and hospitalisations with Multaq when compared with placebo.

The EMA pointed out that the patient population involved in the PALLAS study is different from the population for which Multaq is currently approved.

A review by the Agency's Committee for Medicinal Products for Human Use (CHMP) concerning the benefit-risk balance of Multaq following reports of severe liver injury commenced in January, with the scope of this review now extended to also assess new information from the PALLAS study.

The CHMP will determine the need for any further action at its next meeting on July 18-21, 2011.

12th July 2011

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