Don't Expect Big Push for Celebrex for Juvenile Arthritis

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Celebrex remains available to consumers, but in 2005, the FDA required that the drug carry a "black box" warning on the possible risk of heart attack or stroke.

The severity of this problem in children is unclear.

"Potential cardiovascular toxicity is less of an issue with children because there aren't too many kids who get heart attacks or strokes," Ilowite said. "Down the line the worry is there, but it's not so much of an issue as [it is for] patients who are elderly or who have cardiovascular problems."

"The risk of heart disease is minimal in children," Lindsey added. "The only question would be long-term. If some child takes Celebrex for 15 years, that would be more of a concern."

Side effects will be minimized if the drug is used short-term or intermittently, Lindsey said.

"It's not like a cure. It's just another treatment," he said. "It will help kids who haven't been helped by other anti-inflammatories."

Celebrex is already being used off-label in children, said Dr. Kathleen Haines, a pediatric rheumatologist with the Joseph M. Sanzari Children's Hospital at Hackensck University Medical Center in Hackensack, N. J.

"The sad case is that few new drugs are approved for any cause other than antibiotics, and we do a lot of off-label prescribing because we're forced to," she added.

Haines, who testified at the FDA panel's hearing Wednesday, noted, "In a sense, Celebrex has been available, at least for older kids."

If the FDA does approves this new indication, she said, pediatricians, in addition to rheumatologists, may feel more comfortable prescribing Celebrex even for non-rheumatoid-arthritis conditions, such as tendonitis or sports pain.

"There are a lot of places where it might come into play once it has a pediatric indication," said Haines.

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.

More information

For more on juvenile rheumatoid arthritis, visit the U.S. National Library of Medicine (www.nlm.nih.gov ).