U.S. drug reviewers question Pfizer pain drug data

Last Updated: 2006-11-28 14:21:30 -0400 (Reuters Health)

WASHINGTON (Reuters) - U.S. drug reviewers have questioned Pfizer Inc.'s data showing the pain reliever Celebrex is as effective as an older drug in treating juvenile rheumatoid arthritis, according to documents released on Tuesday.

The Food and Drug Administration will ask an advisory panel that meets Wednesday for input on whether the agency should expand the approved uses of Celebrex to include juvenile rheumatoid arthritis. The panel also will be asked if more studies are needed, an FDA staff summary said.

A Pfizer trial found Celebrex, known generically as celecoxib, provided the same level of pain relief as an older drug, naproxen. "Nonetheless, there are limitations to the design of this non-inferiority trial that raise questions about whether it provides adequate evidence of efficacy of celecoxib" in juvenile rheumatoid arthritis, the FDA reviewers said.

They also said heart risks to children who take Celebrex long term are unknown. Celebrex is part of the COX-2 family of drugs that included Merck & Co. Inc.'s Vioxx, which was pulled off the market in 2004 after a study found prolonged use doubled heart attack and stroke risk.

Celebrex carries a warning that it may raise the chances of serious and possibly fatal cardiovascular problems, as may other non-steroidal anti-inflammatory drugs used to fight pain.

Pfizer, in a separate summary also released on Tuesday, said current data showed Celebrex was "an appropriate treatment" for juvenile rheumatoid arthritis with "a favorable risk-benefit profile."