FDA Warns of Tysabri Liver Risk; Biogen Idec, Inc. (Massachusetts) and Elan Corporation PLC Slide on Woes

Biogen Idec Inc. and Elan Corp. warned doctors of the possibility of serious liver injury in patients being treated with the multiple-sclerosis drug Tysabri. The new warning, in a letter posted on the Food and Drug Administration’s Web site, was recently included in prescribing information for Tysabri use in patients with Crohn’s disease, a chronic, progressive disease marked by inflammation of the bowel. Last month, the FDA approved Tysabri for Crohn’s patients who have failed other treatments, including Johnson & Johnson’s Remicade and Abbott Laboratories’ Humira, although the drug hasn’t yet been launched as a treatment for Crohn’s.

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