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
FRIDAY, Dec. 15 , 2006 (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)."
"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."
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.
Up until now, Celebrex (celecoxib) was approved to treat adults with osteoarthritis and rheumatoid arthritis. In its application to expand that approval to include treatment of JRA, Pfizer included a six-month study that concluded that Celebrex works as well as naproxen in treating young patients.
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.
For more on with juvenile rheumatoid arthritis, visit the U.S. National Library of Medicine.