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