Aventis Arava safety and efficacy update

FDA's Arthritis Drugs Advisory Committee will meet Jan. 30 to hear an update on the safety of Aventis' Arava (leflunomide) and clinical data on improvement of physical function in rheumatoid arthritis. Aventis has been working on labeling updates with FDA regarding hepatic toxicity. Public Citizen's Health Research Group has called for Arava's removal from the market due to toxicity (1"The Pink Sheet" Sept. 16, p. 22). Aventis recently reported data showing similar toxicity between leflunomide and methotrexate, and radiographic data on slowing of arthritis progression in patients. The meeting will be held at the Holiday Inn in Gaithersburg, Md. beginning at 8 a.m. [To watch a 2webcast/video of this meeting, go to FDAAdvisoryCommittee.com]..