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Questions and Answers:
Strengthened Warnings on Bextra
What did FDA do?
FDA approved a new label with upgraded warnings for Bextra. The new label:
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Strengthened the warning about the possibility of serious skin reactions, including two types of reaction that can result in death (Steven-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN))
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Added a new warning about possible heart and blood clotting problems, particularly in patients who have just had coronary artery bypass graft surgery (CABG)
Is Bextra safe for me to take?
Your physician can help answer this question. While all drugs have risks, FDA believes that, based on what we know now, the overall benefit of Bextra outweighs the risk when used in properly selected patients as directed in the approved labeling.
FDA will continue to monitor the side effects related to Bextra and take additional actions as appropriate. As we have previously announced, FDA will also hold a public advisory committee meeting in February to discuss safety concerns of all marketed COX-2 and related drugs, including Bextra.
What is Bextra?
Bextra is a type of pain medication, called COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs), used to treat arthritis and menstrual pain.
Why did FDA strengthen the warnings?
Despite earlier warnings in the Bextra label, the FDA is still receiving reports of serious, potentially fatal, skin reactions such as SJS and TEN. Patients known to have an allergy to sulfa products should not take Bextra.
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Other COX-2 selective NSAIDs and traditional NSAIDs such as naproxen and ibuprofen also have a risk for these rare, serious skin reactions, but these serious side effects appear to occur more often for patients taking Bextra than for other COX-2 agents.
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In addition, results from a new study of more than 1500 patients who had just had cardiac surgery show that patients treated with Bextra for pain were more likely to have heart and blood clotting problems than other patients who did not receive any drug. These problems include heart attack, stroke, deep vein thrombosis (blood clots in the leg), and pulmonary embolism (blood clot in the lung).
What does this mean for me?
Talk to your doctor if you have any concerns about the medications you are taking.
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You should not take Bextra if you are allergic to medications that contain sulfa.
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You should not take Bextra if you have just had CABG surgery.
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You should stop taking Bextra and call your doctor immediately if you develop a rash or sores in your mouth while taking Bextra. Rashes and other skin reactions are most likely to occur in the first 2 weeks of treatment, but can occur at any time during therapy.
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You should also call your doctor if you develop chest pain.
What other problems should I know about?
Bextra can also cause stomach ulcers. You should stop Bextra and call your doctor if you have any of the following:
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Burning pain in your stomach
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Dark stools or blood in your stools
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Vomit that looks like blood or coffee grounds
Why did FDA take this action?
Patients need to have all the information available about the drugs they are taking and their potential side effects, so they can stop the medication and seek immediate treatment if needed.
To report any unexpected adverse or serious events associated with the use of Bextra, you can contact Pfizer, Inc., at 1-800-323-4204 or FDA MedWatch program at 1-800-FDA-1088 or on the Internet at http://www.fda.gov/medwatch/index.html
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