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First Vioxx was removed from the market because of safety concerns. Now sales of Bextra, the same-genre prescription painkiller made by Pfizer, have also been suspended because Bextra has been found to pose an increased risk of heart attack and stroke among users.

The U.S. Food and Drug Administration on April 7, 2005 asked Pfizer to remove Bextra from the market "because the overall risk versus benefit profile for the drug is unfavorable." Concerns include an increased risk of heart attack, stroke and Stevens Johnson Syndrome, a potentially fatal skin allergy.

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The FDA also asked Pfizer to include the government's strictest warning label to its other painkiller, Celebrex. "Today's actions protect and advance the health of the millions of Americans who rely on these drugs every day," said Dr. Steven K. Galson, acting director of the FDA's Center for Drug Evaluation and Research.

In making its decision, the FDA went against the recommendation of a panel of experts that in February concluded the benefits of Bextra outweighed the risk of taking the drug.

A 2004 study presented at a meeting of the American Heart Association had found that patients who took Bextra were more than twice as likely to suffer heart attacks or stroke. The study included 5,930 patients, some taking Bextra and some given a placebo.

"This is a time bomb waiting to go off," Dr. Garret A. FitzGerald, a University of Pennsylvania cardiologist and pharmacologist, told he New York Times after presenting the study data on Nov. 9. "The magnitude of the signal with Bextra is even higher than what we saw in Vioxx.”

Merck & Co. removed Vioxx from the market Sept. 30, 2004. A deluge of lawsuits have followed by people who used the drug and claim to have suffered severe heart attacks and stroke as a result. Many of those lawsuits were filed for patients and their families by Kline & Specter, P.C. If you or someone you know has suffered illness or death as a result of using Bextra, you may want to contact a Bextra lawyer.

One expert, Dr. Curt Furberg, professor of public health sciences at Wake Forest University School of Medicine, who helped conduct the Bextra study, said Bextra presents the same dangers as Vioxx. “Basically, we showed that Bextra is no different than Vioxx,” he told the Times. “And Pfizer is trying to suppress that information.”

Pfizer, the world’s largest drug maker, introduced Bextra in the United States in 2001, two years after Vioxx hit the market. Both are COX-2 inhibitor drugs as is Celebrex, also made by Pfizer.

The Bextra study, which pooled data from patients who participated in a dozen trials, found 2.19 times the number of heart attacks or strokes among patients given Bextra, a pain reliever used to treat osteoarthritis, adult rheumatoid arthritis and severe menstrual cramps.

Tom Kline talks about the recent Bextra recall on Fox News.

Read The Luis Flores Story

Bextra has also been linked to a skin hypersensitivity disorder known as Stevens Johnson Syndrome, or SJS, a potentially life threatening syndrome whose symptoms include painful blistering of the skin.

For its part, Pfizer said it disagrees with the latest FDA decision that Bextra should be withdrawn and that it will hold further discussions with the FDA on returning Bextra to the market. Pfizer in the past has denied problems with Bextra for arthritis patients, saying that the only patients who experienced heart problems were those at very high risk for heart disease.

On Jan. 31, 2005, the nation's largest HMO said its pharmacies would no longer dispense Bextra because of safety concerns. Kaiser Permanente, based in Oakland, Calif., serves 8.2 million customers in nine states and the District of Columbia.

On the same day, the national consumer group Public Citizen renewed its call for the FDA to ban both Bextra and Celebrex after revelation of a 1999 study that showed an increased rate of heart attacks and strokes among Alzheimer’s patients.

In the latest news, released Sept. 13, 2006, two new review studies evaluating the safety of COX-2 inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs) found increased cardiovascular and kidney risks associated with the medications. (See story.)

BEXTRA RESOURCES:

• Drugs.Com
• FDA
• MedicineNet.com
• RxList
• CenterWatch

Kline & Specter, P.C., with more than 30 experienced attorneys (several of whom are also highly regarded doctors), is one of the nation's leading law firms with the ability to litigate Bextra lawsuits. Kline & Specter has the skill, experience and ability to achieve the right result for you and your family.