Bextra

Valdecoxib is used to relieve the pain, tenderness, inflammation (swelling), and stiffness caused by arthritis and to treat painful menstrual periods. Valdecoxib is in a class of nonsteroidal anti-inflammatory medications called COX-2 inhibitors. It works by stopping the body's production of a substance that causes pain and inflammation.

Brand Names:

• Bextra®

Source: National Institute of Health and American Society of Health-System Pharmacists, Inc.,“Valdecoxib��?, The MedMaster™ Patient Drug Information Database, 2005, http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a602011.html (23 May 2007)

Warnings:

As of 4/7/2005 the FDA concluded that the overall risk versus benefit profile is unfavorable, FDA has requested Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. This request is based on

• The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular (CV) events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.
• Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use.
• Lack of any demonstrated advantages for Bextra compared with other NSAIDs.

FDA Public Health Advisory: http://www.fda.gov/cder/drug/advisory/COX2.htm

Source: U.S. Food and Drug Administration, “COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)��?, The FDA Saftey Information and Adverse Event Reporting Program, 2005, http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm (30 May 2007)