Canada. Ezetimebe (Ezetrol) is a cholesterol absorption inhibitor that is classified as a systemic drug because of the enterohepatic recirculation of one of its metabolites. Merck Frosst/Schering Pharmaceuticals have updated the product monograph for ezetimebe to include information from international post-marketing reports of rare, and in some cases serious, adverse events associated with ezetimebe use including myalgia, rhabdomyolysis, hepatitis, acute pancreatitis, thrombocytopenia and suspected interaction between ezetimebe and warfarin. The Patient Information section has been updated with signs and symptoms of hepatic, muscle, and pancreatic adverse events for which early consultation with a physician is recommended. Physicians are advised to monitor closely for adverse muscle events in all those patients who have a history of statin intolerance, to consider the diagnosis of pancreatitis in patients who develop sudden acute abdominal pain during therapy with ezetimebe and to monitor liver function before beginning ezetimebe therapy in patients being or about to be treated with a statin; ezetimebe, in combination with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations of liver transaminases. Additional International Normalized Ratio (INR) measurements are recommended in patients treated with warfarin, and in whom ezetimebe is initiated.

Reference:

'Dear Health-care Professional' letter from Merck Frosst/Schering Pharmaceuticals, 1 February 2005. Available on the internet at www.hc-sc.gc.ca