Group Calls for 2 Arthritis Drug Bans
Public Citizen Says Celebrex, Bextra Share Vioxx's Problems
Similar Drug Pulled From Market continued...
At the same time, the study, known as CLASS, found no difference in the rate of serious stomach or intestinal complications in patients who took Celebrex or ibuprofen, according to Public Citizen's complaint.
Then, in December 2004, the National Institutes of Health abruptly halted a colon polyp study after preliminary data suggested that patients taking Celebrex were up to 3.4 times more likely than those taking a placebo to have a heart attack, stroke, or a sudden, heart-related death.
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.