Canada. Health Canada, in consultation with Biogen Idec Canada, Berlex Canada and Serono Canada is informing health professionals that serious liver injury (e.g. hepatitis) has been reported with beta-interferon therapy for the treatment of multiple sclerosis in a clinical setting; there were three cases of liver failure needing liver transplantation. Rare but serious liver injury occurred mostly in the early months of therapy but also in patients on therapy beyond one year. Physicians should perform periodic liver function tests, particularly in the early months of therapy; dose reduction should be considered if serum ALT (alanine aminotransferase) increases five times above baseline levels. Patients should be made aware of the signs and symptoms of liver injury including yellowing of the skin or eyes (jaundice), nausea and vomiting, easy bruising of the skin, diffuse itching and abdominal pain; patients experiencing any of these symptoms should contact their physician immediately. Product monographs are being revised to provide physicians and pharmacists with this updated safety information regarding liver injury.

Reference:

1. Health Canada Warnings/Advisories, 18 December 2003. Available from URL: http://www.hc-sc.gc.ca

2. ‘Dear Healthcare Professional’ letter from Health Canada, 4 December 2003. Available from URL: http://www.hc-sc.gc.ca