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Hepatotoxicity: LeflunomideLawrence GoldkindDeputy Division Director Division of Anti-Inflammatory, Analgesic and Ophthalmic Drug Products CDER / FDA At approval 1998 hepatic enzyme elevation (ALT) was noted Approved label 1998 “Warnings” Hepatotoxicity In clinical trials, ARAVA treatment was associated with elevations of liver enzymes, primarily ALT and AST, in a significant number of patients; these effects were generally reversible. Most transaminase elevations were mild (2-fold ULN) and usually resolved while continuing treatment. Marked elevations (3-fol