Risk Management Issues Involving Arava: An Excerpt from Dr. Sidney Wolfe's Presentation Before the FDA Arthritis Advisory Committee

photo-1 About the Author Sidney Wolfe, M.D., is the director of Public Citizen's Health Research Group, an advocacy group devoted to protecting consumers from potentially harmful drugs. The following article contains edited excerpts from the transcripts of Dr. Wolfe's March 5, 2003, presentation before the FDA Arthritis Advisory Committee regarding the safety of Arava and risk management issues involving the rheumatoid arthritis drug. On March 28, 2002, Dr. Wolfe submitted a petition to the FDA requesting that the agency ban Arava due to its ability to cause liver damage.

In too many instances, serious …