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Don't Expect Big Push for Celebrex for Juvenile Arthritis

FDA panel recommends its use, but other treatment options exist, experts say

THURSDAY, Nov. 30, 2006 (HealthDay News) -- A U.S. government advisory panel's recommendation to allow Celebrex to be used for children with juvenile rheumatoid arthritis isn't likely to change the treatment landscape dramatically.

More probably, the painkiller will quietly become one more option in the array already available, doctors said.

"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)."

"We're not sure exactly what the role of this drug is going to be in the treatment of juvenile rheumatoid arthritis," Ilowite continued. "The biggest issue is that there will be more choices. There's not really good evidence that Celebrex spares side effects or is particularly effective more than other choices, but for individualized patients it might be."

The Food and Drug Administration panel voted 15-1 on Wednesday 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 FDA isn't bound to follow the recommendations of its advisory panels but typically does.

The short-term side-effect profile of Celebrex is fairly benign, experts said.

"I don't think it's dangerous because I think the dose will be on the low side," Lindsey said. "The safety issues will be reasonably good."

At issue, however, are potential long-term side effects, including cardiovascular side effects.

Celebrex is a member of the controversial group of painkillers called Cox-2 inhibitors, which have been linked to an increased risk of heart attack and stroke. Two other Cox-2s, Vioxx and Bextra, have been withdrawn from the market because of heart-risk concerns.

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.

SOURCES: Norman Ilowite, M.D., chief, division of rheumatology, Montefiore Children's Hospital, and professor of pediatrics, Albert Einstein College of Medicine, New York City; Stephen Lindsey, M.D., section head of rheumatology, Ochsner Health System, Baton Rouge, La.; Kathleen Haines, M.D., pediatric rheumatologist, The Joseph M. Sanzari Children's Hospital, Hackensack University Medical Center, Hackensack, N.J.
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