Benefit-risk review of Sanofi-Aventis's Multaq underway in EU
This article was originally published in Scrip
Executive Summary
"Urgent regulatory action" is needed to help prevent the possible risk of severe liver complications associated with Sanofi-Aventis' anti-arrhythmic Multaq (dronedarone), said the Committee for Medicinal Products for Human use (CHMP) on 21 January. A benefit-risk review of the product is now underway.