Statistically significant increase in thromboembolic events (myocardial infarction, ischemia, cerebrovascular accident, deep vein thrombosis, pulmonary embolism) found in the group treated with Bextra (paracoxib/valdecoxib) post-op as compared to the placebo group. The relative risk for a thromboembolic event was 351 percent.
Montgomery, AL (PRWEB) April 15, 2005
Law firm Beasley Allen, lead counsel for the first Vioxx lawsuit set for May, believes that Pfizer's Bextra, a COX-2 inhibitor, posed a dual danger to thousands of consumers before its withdrawal last week.
"Bextra has not only shown an increased risk for serious cardiovascular events in patients, it has also been linked to Stevens Johnson Syndrome (SJS), a skin disease that produces deadly, widespread lesions," according to attorney Paul Sizemore who is handling 1000 potential Bextra cases for the firm. "Problems with this drug have been recognized for some time in the medical community," says Sizemore.
He cites the Journal of Thoracic and Cardiovascular Surgery as reported in 2003: "Statistically significant increase in thromboembolic events (myocardial infarction, ischemia, cerebrovascular accident, deep vein thrombosis, pulmonary embolism) found in the group treated with Bextra (paracoxib/valdecoxib) post-op as compared to the placebo group. The relative risk for a thromboembolic event was 351 percent."
Sizemore reveals that a second similar study was conducted by Pfizer, with results released in October 2004. This study again showed a statistically significant rise in the incidence of thromboembolic events where the relative risk was 288 percent.
Dr. Garrett Fitzgerald, a cardiologist and pharmacologist at the University of Pennsylvania, said in a New York Times interview on November 10, 2004: "The magnitude of the safety signal with Bextra is even higher than what we saw in Vioxx... this is a time bomb waiting to go off."
Dr. Curt Furberg, Department of Public Health Sciences, Wake Forest University School of Medicine, was quoted in the same article as saying: "Bextra is no different than Vioxx, and Pfizer is trying to suppress that information."
"Pfizer has long ignored the safety signals associated with Bextra, ignored the warnings from leading scientists about its hazards, and ignored the results of multiple clinical studies evidencing a clear safety risk associated with this drug," says Sizemore.
"Were it not for the renewed safety focus within the FDA, no doubt triggered by the Vioxx debacle, Pfizer would have continued to market and profit from a drug whose risks were not only well known, but also well proven,Â adds Sizemore.
Beasley Allen has 36 Bextra lawsuits pending against Pfizer, and another 1,000 cases to be filed. Beasley Allen has been named co-lead counsel on all Vioxx lawsuitsÂthe first is scheduled to come to trial May 23, 2005.
Paul Sizemore, Esq.
800-898-2034 / 334-451-0762
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