The European Commission has requested that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) assess all available data concerning the possible risks of liver injury associated with the use of Multaq and their impact on its benefit-risk balance, after two cases of serious liver injury in patients taking dronedarone (Multaq, Sanofi-Aventis).
The CHMP discussed Multaq during its meeting this month, and concluded that there was a need for urgent regulatory action to help manage the possible risk of severe liver complications with the medicine. The committee recommended that warnings and precautions be introduced into the medicine’s prescribing information, to ensure that patients’ liver function is tested before initiation of treatment and closely monitored during treatment and that treatment is stopped if there are signs of potential liver damage.
Earlier this month, the FDA also alerted healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplants in patients treated with Multaq.
The CHMP review’s outcome will be made public once the committee has reached its final opinion.