28 December 2004

Arthritis drug Bextra found to promote heart attacks and strokes

Following the recent revelations that Vioxx cause a high incidence of heart attacks and strokes, a competing drug from Pfizer, Bextra, has now been shown to display similar health problems. What's especially weighty about this particular revelation is that it comes from the American Heart Association, a disease-industry group that has traditionally acted in favor of pharmaceutical companies. Because of this, the AHA deserves credit for allowing this study to be published.

In the preliminary results, Bextra was found to increase the incidence of heart attacks and strokes by 219%. The cardiologist who presented the study, Dr. Garret Fitzgerald, called Bextra, "A time bomb waiting to go off," and noted that the apparent dangers of Bextra exceed those associated with Vioxx.

Pfizer, of course, downplayed the study in an attempt to minimize any negative backlash from its release. The question remains, however: will Pfizer now follow in Merck's footsteps and voluntarily recall Bextra? And if it refuses to do so, will the FDA step in and finally perform the regulatory function it has been so reluctant to use by banning Bextra from the market? Or will this warning be swept aside in favor of a policy that allows this drug to continue to be sold to tens of millions of Americans, regardless of its questionable safety?
Overview:

NEW YORK - The arthritis drug Bextra, made by Pfizer Inc., has shown a high incidence of heart attacks and strokes among patients, according to an American Heart Association study, the New York Times reported on Wednesday. Bextra is similar to Merck & Co.'s drug Vioxx Merck voluntarily recalled Vioxx from shelves in late September when a study showed it increased the risk of a cardiac event.

        - The AHA's preliminary study of Bextra was unveiled on Monday at a meeting in New Orleans, which pooled data from 5,930 patients taking part in 12 trials.

        - It found 2.19 times the number of heart attacks or strokes among patients given Bextra, compared with those given placebos, the Times reported.

       - "The magnitude of the signal with Bextra is even higher than what we saw in Vioxx.

        - This is a time bomb waiting to go off," Dr. Garret A. FitzGerald, a cardiologist and pharmacologist at the University of Pennsylvania who presented the study, told the Times in an interview.

        - The newspaper said that the new study of Bextra was not considered to be as as persuasive as the trial that led to Vioxx's withdrawal because it was backward-looking and reorganized data that had been presented in other settings.

        - A spokeswoman for Pfizer told the Times that heart problems with Bextra appeared only in studies involving patients at very high risk of heart disease who were undergoing cardiac surgery -- a detail Pfizer disclosed on Oct. 15.

        - Other studies of Bextra, involving 8,000 patients with arthritis who were followed for 6 to 52 weeks, found no heart problems, she told the newspaper.

        - A representative for Pfizer was not immediately available to comment to Reuters early on Wednesday.

By Marc Kaufman
Washington Post Staff Writer

Search Our Canada Pharmacy Prices

close window