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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:
-
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))
-
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.
-
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.
-
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.
-
You should not take Bextra if you are allergic to
medications that contain sulfa.
-
You should not take Bextra if you have just had CABG
surgery.
-
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.
-
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:
-
Burning pain in your stomach
-
Dark stools or blood in your stools
-
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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Date created: December 9, 2004 |
