WASHINGTON – Federal advisers recommended Wednesday that Pfizer Inc. be allowed to market the painkiller Celebrex as a treatment for children with a devastating form of arthritis, even though they split on whether it was safe.
In a 15-1 vote, the advisers said the benefits of the drug outweighed its risks for juvenile rheumatoid arthritis patients 2 and older. They also strongly recommended its safety be monitored for years.
The Food and Drug Administration must now weigh the panel's recommendation that it expand approval of Celebrex. The agency isn't required to follow the advice of its expert panels but usually does.
Earlier, the FDA's arthritis advisory committee voted unanimously to say the drug was an effective treatment for juvenile rheumatoid arthritis, which affects as many as 60,000 U.S. children.
However, in an 8-7 vote, with one abstention, panel members said available data doesn't demonstrate that Celebrex is safe in treating the disease, commonly called JRA.
Celebrex is the only member of a class of drugs that included Vioxx and Bextra not to have been withdrawn from the market over concerns they elevate the risk of heart attacks and strokes in adults. FDA reviewers before the meeting had questioned the cardiovascular risks of long-term use of the drug in children.
"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," said panel member Dr. Joan Bathon, a Johns Hopkins University rheumatologist.
The panel recommended the FDA require Pfizer to study the long-term safety of the drug, possibly by creating a registry of patients that would allow their health to be tracked for 10 to 20 years, Bathon said.
"That's not unreasonable. But the important part, when they considered both safety and benefit, is the benefits outweighed the risks," said Dr. Steven Romano, a vice president in Pfizer's worldwide medical division.
The panel's endorsement came despite an FDA review of the New York company's application that raised questions whether study results showed Celebrex works for the pediatric disease.
Pfizer said the results of a six-month study showed that Celebrex, also known as celecoxib, works just as well as naproxen in treating young patients with rheumatoid arthritis. Naproxen, sold as Aleve and in generic versions, is the most common treatment for JRA.
Bathon said the panel recognized the importance of expanding the pool of treatment options for JRA. Vioxx, until it was withdrawn in 2004, had been the only FDA-approved drug of its class for the disease.
The FDA originally approved Celebrex for use in adults with osteoarthritis and rheumatoid arthritis in 1998.