Pfizer Withdraws Bextra from Market April 7, 2005 - Citing concerns regarding the risk of heart attacks, strokes, "life threatening" skin reactions, and other cardiovascular events the FDA requested that drugmaker Pfizer withdraw Bextra from U.S. and European pharmaceutical markets. If you or a loved one have suffered from the dangerous side effects of Bextra, you should consider receiving a free legal evaluation from our experienced Bextra lawyers.   On December, 17, 2004, a Yahoo News Report stated that Doctors recommend avoiding Pfizer's Bextra, just as a large study found the drug maker's sister drug, Celebrex, doubled risk of heart attacks. Pfizer Inc., had stated that it is going to conduct long-term studies on Bextra – a COX-2 inhibitor like Merck & Co.’s Vioxx, which was withdrawn from the market due to risk of heart attacks and stroke. Pfizer’s studies will examine Bextra’s effects on cardiovascular risk, and is also planning to update the drug’s label with the risk of a rare but serious skin reaction.

The lawyers of Belluck & Fox concentrate in Pharmaceutical Negligence and Product Liability. Legal analysts for prominent news media. Our cases have appeared in leading periodicals, such as Readers Digest and the New York Times. In house expertise, our lawyers litigate your case. Nationally recognized pharmaceutical negligence experts. Pfizer Suspends Bextra Sales 4/07/2005 Pfizer arthritis ads 'misleading' 1/12/2005

Bextra (valdecoxib) is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Valdecoxib works by reducing substances in the body that cause inflammation, pain, and fever, and is used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. Valdecoxib is also used to treat painful menstruation.

After Merck’s voluntary withdrawal of its blockbuster drug, Vioxx, Pfizer took another look at Bextra’s clinical trial database, which includes 8,000 patients treated from six to 52 weeks, and found that the popular painkiller may increase the risk of heart attack or stroke in patients who have had coronary artery bypass surgery. The American Heart Association (November 9, 2004), reported that a preliminary study demonstrated that the incidence of heart attacks and strokes among patients given Pfizer's painkiller Bextra was more than double that of those given placebos. Further studies are planned.

The Vioxx withdrawal has cast long shadows over the entire class of COX-2 inhibitors – which also includes Celebrex and an experimental drug from Novartis AG called Prexige – and has heightened debate about the overall safety of the drugs.

Some of the more serious, possible side effects of Bextra include:

• Abdominal pain, tenderness, or discomfort
• Bloody, black, or tarry stools
• Nausea or heartburn
• Bloody vomit
• Unexplained weight gain
• Swelling or water retention
• Unusual fatigue or lethargy
• Yellowing of the skin or eyes
• Flu-like symptoms
• Unusual bruising or bleeding

Pfizer also said it is updating its label on Bextra to strengthen a warning about a rare but serious skin reaction, Stevens-Johnson syndrome, that can occur mainly within the first two weeks of therapy.

Pfizer has said that although Bextra is not approved for use for surgery patients, its studies had shown that general surgery patients – as opposed to bypass patients – are not at higher risk for heart attacks. Still, some doctors have expressed concern that COX-2 inhibitors do indeed increase the risk of heart problems.

Pfizer’s longer-term trials for arthritis patients studied use of Dynastat and Bextra in patients who had just had coronary artery bypass graft. The first study involved 450 patients, 300 of which received Bextra and Dynastat. All patients had the option of giving themselves morphine and opiates and everyone received low-dose aspirin. The results showed that the Bextra-Dynastat combination was leading to higher adverse event rates.

An additional, larger study involving 1,500 patients confirmed the results.

If you are experiencing any of the above listed side effects, and have taken Bextra, contact Belluck & Fox immediately for a free legal evaluation. Drug litigation can be extremely complex. It is best to seek the counsel of a personal injury attorney with experience in this field of law. Belluck & Fox has substantial experience with defective product litigation, including pharmaceutical and medical product cases. We will provide you with personalized, professional legal representation.

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