FDA OKs Celebrex for Kids With Arthritis

Says benefits outweigh potential risks, but Pfizer will have to keep a long-term registry to evaluate safety issues.

By Amanda Gardner
HealthDay Reporter
Saturday, December 16, 2006; 12:00 AM

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FRIDAY, Dec. 15 (HealthDay News) -- The U.S. Food and Drug Administration Friday gave the green light to Celebrex for use in kids older than two as a treatment for juvenile rheumatoid arthritis.

The agency's action followed an advisory panel recommendation just over two weeks ago, which found that the benefits of the painkiller for children outweighed the shortage of proof on its safety

The panel, a committee of doctors and other specialists, voted 15-1 to approve the expanded use. But it 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.

As part of the approval process, the FDA said Friday, the drug's manufacturer, Pfizer, has agreed to conduct two Phase 4 post-marketing studies: a short-term controlled trial to evaluate high blood pressure, and a several-year registry study to further evaluate long-term safety issues, including renal toxicity, high blood pressure, and cardiovascular events.

"JRA is often a devastating disease," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement. "While there are other medicines approved for the treatment of this disorder, for some children they may have limited effectiveness or cause intolerable side effects. Celebrex will be a needed additional treatment option for children."

His sentiment had been echoed by other experts after the advisory panel sent in its recommendation on Nov. 29.

The painkiller will quietly become one more option in the array already available, doctors said at the time.

"There will not be a mad rush to switch kids over to Celebrex," said Dr. Stephen Lindsey, section head of rheumatology at Ochsner Health System in Baton Rouge, La.

"I don't think there's going to be a huge move to this drug," added Dr. Norman Ilowite, chief of the division of rheumatology at Montefiore Children's Hospital in New York City. "Doctors will try this on patients with gastrointestinal problems who are on conventional NSAIDs (nonsteroidal anti-inflammatory drugs)."