On September 30, 2004, Merck & Co., the manufacturer of the blockbuster arthritis drug Vioxx (rofecoxib), announced the voluntary, worldwide recall of Vioxx after a recent clinical trial confirmed previous studies linking Vioxx to serious cardiovascular problems. Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, the management of acute pain in adults, and the treatment of menstrual symptoms. It is also approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.

The Agency was informed by Merck & Co., Inc. on September 27, 2004, that the Data Safety Monitoring Board for an ongoing long-term study of Vioxx (APPROVe) had recommended that the study be stopped early for safety reasons. The study was being conducted in patients at risk for developing recurrent colon polyps. The study showed an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx compared to placebo, particularly those who had been taking the drug for longer than 18 months. Based on this new safety information, Merck and FDA officials met the next day and during that meeting FDA was informed that Merck was voluntarily withdrawing Vioxx from the market place.

Lives could have been saved if Merck had put the safety of its patients first and heeded early warnings of the drugs harmful effects. On November 14, 2004, the CBS news program 60 Minutes, reviewed allegations that Merck new that Vioxx was unsafe as early as 2000. Days after the recall, Dr. Eric Topol of the Cleveland Clinic publicly criticized the FDA for not requiring Merck to do studies investigating heart problems with Vioxx when hints of such problems first appeared years ago.

The risk that an individual patient taking Vioxx will suffer a heart attack or stroke related to the drug is very small. Patients who are currently taking Vioxx should contact their physician for guidance regarding discontinuation and alternative therapies.