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BEXTRA® - Reactions!
According to a report published in the Financial Times, pooled analysis of data presented to the American Heart Association from 5,000 patients in 12 clinical trials on BEXTRA® (valdecoxib) have found the risk of heart attack or stroke was 2.14 times higher than for patients on placebos.
One expert, Dr. Curt Furberg, professor of public health sciences at Wake Forest University School of Medicine, who helped conduct the latest BEXTRA® study, says 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."
Garret FitzGerald of the University of Pennsylvania, said he hopes his findings will prompt the Food and Drug Administration to warn against giving the drug to patients with heart disease - and examine whether the risk posed by Vioxx® extends to every member of its drug class, called Cox-2 inhibitors
"We think that BEXTRA®'s withdrawal is already being reflected in the stock," analyst Barbara Ryan at Deutsche Bank said, adding that it was difficult to predict whether Pfizer would actually take it off the market.
Additionally, after the FDA refused Pharmacia's request to approve BEXTRA® for use in situations of acute pain relating to impacted molars (BEXTRA® is only permitted for chronic pain related to arthritis, osteoporosis and menstrual cramps), the company partially funded a research study that suggested the drug would be useful in fighting acute dental pain. That study duly found its way into dental journals and the company was sued for allegedly secretive encouragement of 'off label' uses and attempting to circumvent the FDA's refusal.
"Over and over again, in more and more cunning ways, the pharmaceutical industry is putting profit ahead of consumers' physical and financial well-being," said an attorney linked to the case. "The FDA regulations exist to protect consumers and Pharmacia's efforts to circumvent those regulations without regard for anything but its own bottom line must stop. " Clearly the fact that some people are suffering from Stevens Johnson Syndrome because of BEXTRA® is of less importance to these companies than the potential to increase profits with the drug. |