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FDA Cox-2 Safety Advisory

FDA Bextra Recall

On 4/7/05 the U.S. Food & Drug Administration asked Pfizer, the manufacturer of the Bextra drug, to recall the popular pain medication from shelves across the U.S. due to risks of serious life-threatening side effects including heart attacks, strokes, Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) in patients.

Canada Health quickly followed suit and asked Pfizer to recall Bextra from Canadian shelves. In addition, Pfizer has also suspended sales of Bextra in the European Union.

Update: Schmidt & Clark is only accepting Bextra induced SJS cases.

If you or a loved one have taken Bextra and developed SJS, you should contact us immediately. You may be entitled to compensation and we can help.

What is the Problem?

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

As with all pharmaceuticals, Bextra comes with its list of side effects.

Bextra Side Effects and Recall

The popular painkiller Bextra (Valdecoxib), used by millions of Americans to relieve symptoms of acute arthritis and painful menstrual cycles, may double the risk of heart attacks and strokes.

On April 7, the FDA requested that Pfizer suspend sales in the United States due to the increased risk of cardiovascular events and the development of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis.

Although Pfizer claimed that Bextra was chemically different than Vioxx and did not present the same heart-related risks, Dr. Garret FitzGerald, a cardiologist and pharmacologist at the University of Pennsylvania, presented data in November proving that patients taking Bextra have a 2.19 times greater risk of experiencing a severe coronary event such as a heart attack, stroke or death. According to Dr. FitzGerald,

"The magnitude of the signal with Bextra is even higher than what we saw with Vioxx. This is a time bomb waiting to go off."

Pfizer recently warned doctors that Bextra can cause a rare but dangerous skin reaction called Stevens Johnson Syndrome. Bextra now carries a "black box" warning about these skin reaction risks, which is the final warning step before a recall.

Do I have a Bextra Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Bextra lawsuits. We are handling individual litigation nationwide and currently accepting new Bextra cases in all 50 states.

Attention Attorneys: We do not publish prior verdict/settlements. If you are an attorney and would like to refer us a case or for us to send you a profile of prior award judgments or average referral fees, please visit the attorney referral section of our website.

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Bextra Side Effects and Recall / Lawsuit News (National)

Pfizer settles Bextra suits for $894 million - San Francisco Gate
Saturday, October 18, 2008 Drug giant Pfizer Inc. has reached an $894 million deal to settle the bulk of the lawsuits over its withdrawn pain reliever Bextra, following the lead of rival Merck & Co., which is spending five times as much to settle ...

2nd UPDATE: Pfizer Agrees To Pay $894 Million To Settle Litigation - CNN Money
Pfizer Inc. (PFE) agreed to pay $894 million to settle the bulk of litigation and state government probes surrounding its pain drugs Celebrex and Bextra, which were linked to increased risk for heart attacks and strokes. The New York drug maker said ...

Pfizer To Settle Bextra, Celebrex Lawsuits - Post Chronicle
Pfizer Inc said on Friday it plans to pay $894 million to settle lawsuits alleging that its withdrawn Bextra painkiller and widely used Celebrex arthritis drug harmed U.S. patients and defrauded consumers. Pfizer said the money would be paid out ...

Pfizer Takes Bextra Off Market at FDA Request - Senior Journal
Agency orders new warning labels on Cox-2 and other NSAID medications April 7, 2005 ? The Food and Drug Administration today asked Pfizer to withdraw Bextra from the market and announced new label warnings for the non-steroidal anti-inflammatory ...

Pfizer completes part of painkiller settlement - Seattle Post Intelligencer
NEW YORK -- Pfizer Inc. said Wednesday it finalized part of a larger, $894 million deal to settle lawsuits over its promotion of the painkillers Celebrex and discontinued Bextra. The company made official a deal that would pay $60 million to settle ...

Pfizer to settle for $894 million - Seattle Post Intelligencer
TRENTON, N.J. -- Drug giant Pfizer Inc. has reached an $894 million deal to settle the bulk of the lawsuits over its withdrawn pain reliever Bextra, following the lead of rival Merck & Co., which is spending five times as much to settle Vioxx suits ...

Michigan included in $60 million settlement with Pfizer Inc. over ... - Kalamazoo Gazette
LANSING, MI -- Michigan is part of a $60 million, 33-state settlement with Pfizer Inc. over its promotion of the painkillers Celebrex and discontinued Bextra. Pfizer Inc. said Wednesday it finalized its deal with state attorneys general, part of a ...

Pfizer's $894 million settlement ends lawsuit pain - San Francisco Gate
Drug giant Pfizer Inc. has reached an $894 million deal to settle the bulk of the lawsuits over its withdrawn pain reliever Bextra, following the lead of rival Merck & Co., which is spending five times as much to settle Vioxx suits. The Pfizer ...

Pfizer settles $894 Million Celebrex/Bextra Lawsuit - Eyewitness News
TRENTON, N.J. (from the Associated Press)-Drug giant Pfizer Inc. has reached an $894 million deal to end most of the lawsuits over its two prescription pain relievers, the popular Celebrex and a similar drug, Bextra, no longer on the market. The ...

Pfizer settles suits over Celebrex, Bextra - WPVI
TRENTON, N.J.; October 17, 2008 -- Drug giant Pfizer Inc. has reached an $894 million deal to end most of the lawsuits over Celebrex and a similar pain reliever, Bextra - no longer on the market. The world's biggest drugmaker said Friday it has ...



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