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.
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Brand Names:
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.
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)
For more information on drugs recently recalled by the U.S. Food and Drug Administration (FDA), please go to: US FDA: Recalls, Market Withdrawals and Safety Alerts.
Bextra® is a registered trademark of Pfizer Inc.