Benefit-risk Review of Multaq Started

The European Commission has requested the Agency’s Committee for Medicinal Products for Human Use assess all available data concerning the possible risks of liver injury.

Further to the report of two cases of serious liver injury in patients taking the anti-arrhythmic medicine Multaq (dronedarone), the European Commission has requested that the Agency’s 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.

The Committee discussed Multaq during its January 2011 meeting 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 ther