FDA Launches Vioxx Drug Center on the Web.

Vioxx (rofecoxib)

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. Vioxx was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.

Statement by Dr. Steven Galson, Acting Director, Center for Drug Evaluation and Research (CDER), Regarding November 18, 2004, Committee on Finance of the U.S. Senate Hearing on Drug Safety and the Worldwide Withdrawal by Merck & Co., Inc., of Vioxx. FDA Statement (11/18/2004) Congressional Statement on Vioxx and Drug Safety (Posted 11/18/2004)

FDA releases a statement on Vioxx and recent allegations, and on the Agency?s continued commitment to sound science and peer review. FDA Statement (Posted 11/17/2004)

Slide Presentation by Sandra Kweder, M.D., November 10, 2004. [HTML] [PowerPoint] (Posted 11/10/2004)

FDA Acts to Strengthen the Safety Program for Marketed Drugs. FDA Statement (11/5/2004)

9/30/2004 Study Report (Posted 11/2/2004)

FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product. FDA News (9/30/2004)

FDA Public Health Advisory: Safety of Vioxx (9/30/2004)

Vioxx (rofecoxib) Questions and Answers (9/30/2004)