The European Medicines Agency is currently reviewing the benefit-risk balance of the antiarrhythmic agent dronedarone (Multaq^®). New study data (PALLAS study) indicate a significantly increased risk of cardiovascular adverse events in patients with permanent atrial fibrillation due to treatment with dronedarone. In January 2011 the CHMP already initiated a procedure to review the benefit-risk balance following reports of severe liver injury including hepatic failure due to dronedarone.

risk information - full text (available in German only)

EMA: European Medicines Agency updates on ongoing benefit-risk review of Multaq.