Pharmacy Daily | EMA reviews Multaq

THE European Medicines Agency is reviewing the cardiovascular risk profile of the anti-arrhythmic drug Multaq (dronedarone) approved for use in non-permanent atrial fibrillation patients, following the cessation of the PALLAS study (PD yesterday). Manufactured by Sanofi-Aventis, the drug was being trialled in patients with permanent atrial fibrillation, however the trial was stopped after the occurrence of severe cardiovascular events in some patients. The EMA’s Committee for Medicinal Products for Human Use (CHMP) started a review in January 2011 of the overall benefit-risk of Multaq following reports of severe liver injury, and as a result of the PALLAS research the review will now be expanded to assess the information contained in the study. The EMA has said that the CHMP will determine the need for any further action at its next meeting taking place between 18-21 July.

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