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Concerns for cardiovascular related Bextra® side effects have been raised in the media again, following new reports on the dangers of the Cox-2 Inhibitor family of drugs. On February 16, 2005, the FDA's panel to evaluate the safety of these drugs featured testimony from Merck & Co. who told FDA advisers that research linking its withdrawn Vioxx to heart attacks and strokes may apply to the entire class of painkillers, including Celebrex® and Bextra®.
Bextra News from the New York Times, November 22, 2004
Washington - At a hearing Thursday on Capitol Hill, senators excoriated top federal drug regulators for failing to realize three years ago that Vioxx, a pain pill that Merck withdrew in September, was dangerous. But the Food and Drug Administration today faces almost exactly the same situation with another arthritis drug, Bextra, that it did with Vioxx three years ago. And just as with Vioxx, it is far from clear what the agency should do. Read more of the story
According to a study conducted by cardiologist Dr. Garrett Fitzgerald of the University of Pennsylvania, the incidence of heart attacks and strokes among patients given Bextra is two times that of patients taking placebo. Fitzgerald's study pooled data from 5,930 patients taking part in 12 trials.
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As the article and Dr. Garrett Fitzgerald suggest, Bextra® users
may have an increased risk for serious cardiovascular side effects
including strokes, heart attacks, heart failure, blood clots and even
death. Like the recently recalled drug Vioxx, Bextra® is a member of
the COX-2 inhibitor family and shares some of the criticisms that
forced Merck to withdraw Vioxx® from the market on September 30,
2004.
Bextra® (valdecoxib) has been sold since 2002 and is marketed
by Pfizer and Pharmacia for the treatment of pain and tenderness
associated with osteoarthritis and adult rheumatoid arthritis.
Bextra® has been further associated with skin hypersensitivity
disorders and Stevens Johnson Syndrome, an acute allergic
reaction. Symptoms of such adverse reactions include blistering,
sores, swelling, cough, and fever.
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