In April 2005, The U.S. Food and Drug Administration announced actions which will be taken regarding the marketing of NSAIDs (non-steroidal anti-inflammatory drugs). The actions include changes for COX-2 inhibitors, as well as prescription and non-prescription (over-the-counter) NSAIDs.
These actions by the FDA follow scrutiny of NSAIDs and COX-2 inhibitors provoked by the voluntary withdrawal of Vioxx by Merck in September 2004. After analyzing scientific data, including data collected after the drugs were approved, and a joint meeting of the FDA's Arthritis and Drug Safety and Risk Management Advisory Committees held February 16-18, 2005, the FDA made its decision.
COX-2 inhibitor drugs include:
- Celebrex (Celecoxib)
- Vioxx (Rofecoxib)(No longer on market as of September 2004)
- Bextra (Valdecoxib)(No longer on market as of April 2005)
There are also other COX-2 Inhibitors being developed, including:
More Information On NSAIDs And COX-2 Inhibitors
Cox-2 Inhibitors, MedicineNet 10/2/2005.
Questions and Answers: FDA Regulatory Actions for the COX-2 Selective and Non-Selective Non-Steroidal Anti-inflammatory drugs (NSAIDs). FDA/Center for Drug Evaluation and Research. April 7, 2005.