Study Connects Bextra to Heart Problems

Published Online: Wednesday, December 1, 2004

The results of a preliminary study, reported November 9, 2004, at the American Heart Association meeting, found that patients given Pfizer's Bextra (valdecoxib) had double the risk of heart attacks and strokes, compared with patients taking placebos. The findings are based on data from 5930 patients enrolled in 12 trials. Bextra is in a class of drugs known as cyclooxygenase-2 inhibitors. Merck & Co Inc recently withdrew VIOXX (rofecoxib), a drug similar to Bextra, after a lengthy study indicated that it doubled the risk of heart attack and stroke.

"The magnitude of the signal with Bextra is even higher than we saw in VIOXX," said Garret A. FitzGerald, MD, after presenting the data. "This is a time bomb waiting to go off." Susan Bro, spokeswoman for Pfizer, said that the heart problem involving Bextra showed only in studies involving patients at greater risk for heart disease who were having cardiac surgery—a disclosure Pfizer made in October 2004, as reported in the New York Times, November 10, 2004.

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