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Home > Medical Professionals > FDA Announcements > Market Withdrawal of Vioxx

Market withdrawal of Vioxx (rofecoxib) due to increased risk of cardiovascular events

Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx.  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, for the management of acute pain in adults, and for the treatment of menstrual symptoms, and was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.

Read the 2004 MedWatch safety summary, including links to the Public Health Advisory, press release, and Q&As, at:

http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#vioxx