Health Canada Endorses Increased Safety Info for Ketek
October 31, 2006 11:53

Based on information in published case reports and post-market adverse event reports, the Canadian Product Monograph has been revised to include information on severe and sometimes fatal hepatotoxicity in patients taking Ketek. The Product Monograph also includes updated information regarding loss of consciousness and the use of Ketek in patients with myasthenia gravis. Most post-marketing cases of hepatic dysfunction were reversible after discontinuation of Ketek. However cases of severe hepatotoxicity, including necrosis, hepatic failure, and death have occurred. (Doctors Guide)