A Brief History of Celebrex and Bextra
Nov. 30: Meeting with analysts, a Pfizer executive says the results of the Bextra tests involving heart bypass surgery patients will be added to a revised label. The label is changed on Dec. 3; the FDA doesn't issue an announcement until Dec. 9. "Bextra is not approved for use in the treatment of postoperative pain of any type," the agency says. "However, the FDA believes that these new findings should be made available to health care professionals and patients."
Nov. 30: Pfizer says it will submit to the FDA by year-end an application for Dynastat. This is the intravenous COX-2 drug tested with Bextra during the heart bypass surgery and general surgery clinical trials. Although not available in the U.S., Dynastat is sold in 45 countries.
Dec. 17: Pfizer says that one of two clinical trials examining Celebrex as a possible treatment for certain colon polyps demonstrated an increased cardiovascular risk over a placebo. However, the other trial revealed no greater cardiovascular risk than a placebo. "The cardiovascular findings in one of the studies are unexpected and are not consistent with the reported findings in the second study," Pfizer says. Most patients in both tests took higher doses than the average amount recommended for people with arthritis and pain.
Pfizer says it is studying the results and communicating with U.S. and foreign regulators as well as physicians and patients. Pfizer says it has no plans to withdraw Celebrex. The FDA says it is reviewing the data. Pfizer later says it will suspend direct-to-consumer advertising for Celebrex until the FDA responds.
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