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Group Calls for 2 Arthritis Drug Bans

Public Citizen Says Celebrex, Bextra Share Vioxx's Problems

Similar Drug Pulled From Market continued...

Pfizer said at that time that it was taking steps to address the new data revealed in the NIH study, and it also pointed to another large-scale NIH trial showing no increased cardiovascular risk due to Celebrex. The company issued a statement several days later urging doctors to use "the lowest effective dose" of Celebrex in patients with joint pain due to arthritis or other causes.

Pfizer did not respond to requests for comment on Monday's petition to the FDA.

An FDA spokesperson says the agency plans to review the petition "very carefully." The agency is planning to convene an expert advisory committee next month to conduct a broad review of Cox-2 inhibitor drugs.

More Questions About Bextra

An analysis slated for publication next week in the medical journal Circulation also questions the safety of Bextra by concluding that the drug caused a more than threefold increased risk of cardiovascular side effects in patients who had undergone heart bypass surgery.

Curt D. Furberg, MD, the study's lead researcher, tells WebMD that while the analysis was limited to patients already at high risk of heart attack, as many as half of all arthritis patients also meet criteria for heart disease risk. Bextra's safety has not been adequately studied in the general population since the studies used to gain FDA approval generally excluded those deemed at risk for cardiovascular problems, he says.

"This is the best we've got. Generalizable studies haven't been done," says Furberg, a professor of pubic health sciences at the Wake Forest University School of Medicine.

Furberg declined to comment directly on calls to ban Celebrex and Bextra. But he says data are mounting to suggest that the benefits of Cox-2 inhibitor drugs may not be worth their risks.

"My general view is that the cloud over all the Cox-2 drugs is getting darker and darker," he says.

The FDA in December issued a public warning of the risks of Cox-2 inhibitor use and announced it was strengthening Bextra's product label to alert doctors and patients of cardiovascular risks.


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