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Vioxx (rofecoxib)
Source: FDA
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)
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