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Questions and Answers From the FDA: Strengthened Warnings on Valdecoxib.

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Bextra Lawsuit Information: Questions and Answers From the FDA: Strengthened Warnings on Valdecoxib

[The following information about Bextra safety is reproduced for your convenience from the FDA's website at: http://www.fda.gov/cder/drug/infopage/bextra/bextraQA.htm]

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.

### [End of FDA document quote]

If you have taken Bextra, and you have suffered a heart attack or stroke (or other serious complication including the above listed skin disorders), you have certain legal rights, and you may have a legal case against Pfizer, the maker of Bextra. You should contact a Bextra lawyer as soon as possible.

Our law firm is currently investigating potential cases against Pfizer, and if you think that you may have been harmed by Bextra, you are strongly encouraged to contact us. There is no charge, and no obligation. If we take your case, there is no fee for our services unless we win your case, or settle it in your favor.

On the other hand, if you fail to protect your legal rights now, you may lose the right to be compensated for your harm. (Persons seeking to preserve any potential legal claims should contact an attorney promptly, since all states have mandatory time periods in which lawsuits must be filed with the courts; otherwise, they may be forever barred).

Our firm has a great deal of experience in representing plaintiffs in “drug” cases, and in fact, is currently pursuing numerous cases against “Metabolife” for very similar injuries.

In addition, we have the resources to handle our own cases. This means that when you call our firm, you talk to your own lawyer who has been assigned to your own case.

Please contact us now (your privacy is assured). The secure form below only takes a couple of minutes to fill out, but if you are uncomfortable sending your information over the internet, please call our toll-free number at 800.921.1776 to speak to an attorney. The call is free, and there is no obligation. Act now, as delays can harm your case.

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