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First Vioxx was removed from the market because of safety concerns. Then sales of Bextra, the same-genre prescription painkiller made by Pfizer, were also suspended because Bextra was 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.
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 followed by people who used the drug and claim to have suffered severe heart attacks and stroke as a result. Kline & Specter handled cases involving both Vioxx and Bextra.
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.
Bextra was also 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.
Bextra Resources
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For a free evaluation of your Bextra claim contact our experienced Bextra attorneys today. We will evaluate your Bextra lawsuit and help you get the result you deserve.
