MedWatch alert for Tysabri
Executive Summary
Biogen Idec and Elan are issuing a "Dear Healthcare Professional" letter alerting physicians about a risk of hepatotoxicity with Tysabri use. FDA updated the Warnings section of natalizumab labeling in January to include reports of significant liver injury. The multiple sclerosis treatment, which recently was approved for Crohn's disease, has an extensive risk management plan in place limiting prescriptions and distribution to healthcare practitioners registered with the TOUCH program (1"The Pink Sheet," Jan. 21, 2008, p. 9)