ROCKVILLE, Md. -- An FDA advisory panel said Wednesday that the Cox-2 inhibitor Celebrex (celecoxib) should be approved for treatment of pain associated with juvenile rheumatoid arthritis.
ROCKVILLE, Md., Nov. 30 -- An FDA advisory panel said Wednesday that the Cox-2 inhibitor Celebrex (celecoxib) should be approved for treatment of pain associated with juvenile rheumatoid arthritis.
The panel voted 15-to-one to recommend the approval, even though eight advisers said the available data did not demonstrated that Celebrex was safe for treating juvenile rheumatoid arthritis.
But when push came to shove, the members agreed that the benefits of the drug outweighed its risks in rheumatoid arthritis patients ages two and older. The advisers did, however, recommend careful monitoring of the drug, perhaps by registry, if it is approved for this JRA indication.
Just as in adults, Celebrex demonstrated good short-term safety, said rheumatologist Joan M.Bathon, M.D., of Johns Hopkins in Baltimore, a panel member. But long-term safety has yet to established, she said.
Pfizer, which markets Celebrex, estimated that 60,000 children in the U.S. have JRA.
A company study indicted that Celebrex is about as effective as naproxen in treating children, and both drugs had similar side effects.
Celebrex is the only Cox-2 inhibitor currently on the market. Merck's blockbuster Cox-2 drug, Vioxx (rofecoxib), was voluntarily taken off the market in September 2004 when clinical trials linked the drug to increased risk of cardiovascular events.
Bextra (valdecoxib), a Cox-2 drug marketed by Pfizer, was withdrawn in the first quarter of 2005 when it, too, was linked to increased risk of cardiovascular events.