Don't Expect Big Push for Celebrex for Juvenile Arthritis

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

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

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THURSDAY, Nov. 30 (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 Two other Cox-2s, Vioxx and Bextra, have been withdrawn from the market because of heart-risk concerns.