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A Brief History of Celebrex and Bextra

Oct. 15: Pfizer says a review of Bextra clinical trial data covering nearly 8,000 patients shows that there is "no increased risk" of heart attack or stroke for patients taking the drug for six to 52 weeks as a treatment for osteoarthritis or rheumatoid arthritis.

However, Pfizer also reviewed results of two studies involving patients who received Bextra after undergoing heart bypass surgery. In one study, patients who received Bextra plus another COX-2 drug unavailable in the U.S. showed a statistically significant high cardiovascular risk. In the other study, patients receiving Bextra alone had a higher risk; but Pfizer later says these results are not statistically significant. Pfizer says a third study of patients undergoing general surgery found no significant risk of cardiovascular problems among those receiving Bextra and the other COX-2 drug. Bextra is not approved in the U.S for any postsurgical care.

Oct. 15: Pfizer says it will conduct additional studies "to confirm the long-term cardiovascular safety profile" of Bextra in patients who require chronic treatment for arthritis.

Oct. 18: Pfizer says it will conduct a new test of Celebrex to assess its effect on osteoarthritis patients at high risk for heart disease. The study is part of a larger cardiovascular testing program with Celebrex that started in 2002. The new trial is expected to start early in 2005. The test will take two years. Pfizer says some previous small tests "suggest that Celebrex's anti-inflammatory properties, as well as additional unique Celebrex-specific characteristics, may improve vascular function in patients with established coronary artery disease."

Nov. 10:: A report in The New York Times quotes Dr. Garrett FitzGerald as saying people taking Bextra have more than twice the risk of heart attacks and strokes compared with people who took placebos. He bases his comments on pooling data from 5,930 patients participating in 12 clinical trials. FitzGerald says Bextra "is a time bomb waiting to go off." Pfizer says the article "draws unsubstantiated conclusions about the cardiovascular safety" of Bextra and "has not been ... subject to independent scientific review. "
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