Updated June 08, 2015.
It came as a surprise when the U.S. Food and Drug Administration asked Pfizer to withdraw Bextra (valdecoxib) from the market on April 7, 2005. According to bextra.com, Pfizer "respectfully disagrees" with the FDA's position on the risk versus benefit profile of Bextra, but has agreed to withdraw Bextra from the market in the United States. At the request of European regulators, Pfizer also will stop selling Bextra in the European Union.
Pfizer is also in discussions with other regulatory agencies around the world.
According to Pfizer and the FDA, you should stop taking Bextra and contact your physician to discuss alternative treatments.
Yes, if you have more questions you can call the Bextra Customer Support Center at 1-866-623-9872.
Sources: FDA Alert for Healthcare Professionals Valdecoxib (marketed as Bextra), FDA/Center for Drug Evaluation and Research, April 7, 2005
Press Release, Bextra.com
Bextra Withdrawn from Market
It came as a surprise when the U.S. Food and Drug Administration asked Pfizer to withdraw Bextra (valdecoxib) from the market on April 7, 2005. According to bextra.com, Pfizer "respectfully disagrees" with the FDA's position on the risk versus benefit profile of Bextra, but has agreed to withdraw Bextra from the market in the United States. At the request of European regulators, Pfizer also will stop selling Bextra in the European Union.
Pfizer is also in discussions with other regulatory agencies around the world.
If You Were Currently Taking Bextra What Should You Do?
According to Pfizer and the FDA, you should stop taking Bextra and contact your physician to discuss alternative treatments.
Can You Get a Refund for Unused Bextra Tablets?
- You may bring your unused Bextra tablets to your local pharmacy and request a refund.
- You may contact the National Notification Center at 1-866-608-3935 to receive a patient product return kit by mail. The National Notification Center will then process your refund.
Is There a Bextra Customer Support Center?
Yes, if you have more questions you can call the Bextra Customer Support Center at 1-866-623-9872.
What Actions Were Taken by the FDA?
- FDA Announces Changes For All NSAIDs; Bextra Withdrawn From Market
The U.S. Food and Drug Administration has announced actions which will be taken regarding the marketing of NSAIDs (nonsteroidal anti-inflammatory drugs). The actions include changes for COX-2 inhibitors, as well as prescription and non-prescription (over-the-counter) NSAIDs. The most significant action is the withdrawal of Bextra from the market.
- Questions & Answers: FDA Regulatory Actions on COX-2 Inhibitors & NSAIDs
The FDA answers questions regarding its action regarding all NSAIDS and specifically the withdrawal of Bextra.
Related Resources
Sources: FDA Alert for Healthcare Professionals Valdecoxib (marketed as Bextra), FDA/Center for Drug Evaluation and Research, April 7, 2005
Press Release, Bextra.com