Study Connects Bextra to Heart Problems

The results of a preliminary study, reportedNovember 9, 2004, at the AmericanHeart Association meeting, foundthat patients given Pfizer's Bextra (valdecoxib)had double the risk of heartattacks and strokes, compared withpatients taking placebos. The findingsare based on data from 5930 patientsenrolled in 12 trials. Bextra is in a class ofdrugs known as cyclooxygenase-2 inhibitors.Merck & Co Inc recently withdrewVIOXX (rofecoxib), a drug similar to Bextra,after a lengthy study indicated that itdoubled the risk of heart attack andstroke.

"The magnitude of the signal with Bextrais even higher than we saw in VIOXX,"said Garret A. FitzGerald, MD, after presentingthe data. "This is a time bombwaiting to go off." Susan Bro, spokeswomanfor Pfizer, said that the heartproblem involving Bextra showed only instudies involving patients at greater riskfor heart disease who were having cardiacsurgery—a disclosure Pfizer madein October 2004, as reported in the NewYork Times, November 10, 2004.