FDA Panel Backs Celebrex for Kids With Arthritis

Says benefits outweigh potential risks to those with juvenile rheumatoid arthritis.

By Amanda Gardner
HealthDay Reporter
Thursday, November 30, 2006; 12:00 AM

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WEDNESDAY, Nov. 29 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel recommended Wednesday that use of the painkiller Celebrex be expanded to treat children with juvenile rheumatoid arthritis.

The panel, a committee of doctors and other specialists, voted 15-1 that the benefits of the drug for children with juvenile rheumatoid arthritis (JRA) outweigh the shortage of proof on its safety.

However, the panel also voted 8-7, with one abstention, that available data doesn't demonstrate that Celebrex is safe in treating JRA and that a registry should be established to track these young patients for 10 to 20 years.

"The feeling was short-term efficacy looked good and short-term safety was not an issue. Long-term safety is totally unknown and needs to be known," Dr. Joan Bathon, a Johns Hopkins University rheumatologist and panel member, told the Associated Press.

"That's not unreasonable. But the important part, when they considered both safety and benefit, is the benefits outweighed the risks," Dr. Steven Romano, a vice president in Pfizer's worldwide medical division, told the AP.

"This decision means that one additional therapeutic choice is available for patients and doctors," Dr. Jeffrey Greenberg, director of the Arthritis Translational Research Registry at New York University Hospital for Joint Diseases, told HealthDay.

"Any unknown, long-term cardiovascular risk associated with the use of Celebrex will need to be factored into the decision," he added.

The FDA is not required to follow the recommendations of its advisory committees, but it usually does.

It's estimated that as many as 60,000 children in the United States have JRA, which causes painful joint swelling and can affect growth and development.

Currently, Celebrex is approved to treat adults with osteoarthritis and rheumatoid arthritis. In its application to expand that approval to include treatment of JRA, drug maker Pfizer Inc. included a six-month study that concluded that Celebrex (celecoxib) works as well as naproxen in treating young JRA patients.