Vioxx withdrawal raises many questions concerning drug policy

Jan 24 2005

Daniel H. Solomon, M.D., M.P.H., from Brigham and Women’s Hospital, Boston, and Jerry Avorn, M.D., of Harvard University School of Medicine, write in the January 24 issue of Archives of Internal Medicine that the withdrawal of rofecoxib (Vioxx) from the market in September 2004 by its manufacturer, Merck & Co., “raises many questions concerning drug policy, scientific evidence, and treatment alternatives.

“Several lessons can be learned from the 5-year experience and eventual withdrawal of rofecoxib from the market. First, the current postmarketing surveillance system does not work. If the FDA is to continue to approve drugs rapidly, we should not expect that all safety issues will be understood prior to a drug’s approval.” The editorial authors add that an improved system of postmarketing surveillance is needed.

“Fortunately, many patients taking coxibs can be switched to other equally effective and evidence-based analgesic (pain relieving) regimens.”

“The market withdrawal of rofecoxib has brought to the forefront concerns about the drug safety system that have been raised before. These issues must be addressed now if we are to restore the public’s confidence in the safety of our pharmacologic armamentarium and provide physicians and patients with the data we all need to prescribe drugs safely.”