Thursday, November 30, 2006

FDA Panel Backs Celebrex for Kids With Arthritis

(HealthDay News) -- A U.S. Food and Drug Administration advisory panel recommended Wednesday that use of the painkiller Celebrex be expanded to treat children with juvenile rheumatoid arthritis.

The panel, a committee of doctors and other specialists, voted 15-1 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 feeling was short-term efficacy looked good and short-term safety was not an issue. Long-term safety is totally unknown and needs to be known," Dr. Joan Bathon, a Johns Hopkins University rheumatologist and panel member, told the Associated Press.

"That's not unreasonable. But the important part, when they considered both safety and benefit, is the benefits outweighed the risks," Dr. Steven Romano, a vice president in Pfizer's worldwide medical division, told the AP.

"This decision means that one additional therapeutic choice is available for patients and doctors," Dr. Jeffrey Greenberg, director of the Arthritis Translational Research Registry at New York University Hospital for Joint Diseases, told HealthDay.

"Any unknown, long-term cardiovascular risk associated with the use of Celebrex will need to be factored into the decision," he added.

The FDA is not required to follow the recommendations of its advisory committees, but it usually does.

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.

Currently, Celebrex is approved to treat adults with osteoarthritis and rheumatoid arthritis. In its application to expand that approval to include treatment of JRA, drug maker Pfizer Inc. included a six-month study that concluded that Celebrex (celecoxib) works as well as naproxen in treating young JRA patients.

Bathon said that the panel recognized the importance of expanding the pool of treatment options for JRA. Vioxx, until it was withdrawn in 2004, had been the only FDA-approved drug of its class for the disease.

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.

During public testimony before the advisory committee Wednesday morning, a New Jersey father said Celebrex had worked wonders for his son, who suffers from juvenile rheumatoid arthritis.

Vincent Del Gaizo, of Whitehouse Station, told the panel members that his son Christopher, now 6, had been in such pain from the disease and was taking so many drugs, he could only sleep three hours a day. Each morning, the boy sat in a high chair with his arms raised for hours because it hurt too much to lower them, the Boston Globe reported.

"It's an image that will be burned in my mind forever," said Del Gaizo, 38. The boy's doctor had "the courage" to try Celebrex "off-label," and now Christopher is able to play soccer and T-ball, his father said.

Also Wednesday, British researchers said they've discovered why Vioxx and other cox-2 inhibitors can cause heart attacks and strokes, BBC News reported.

The reason: These drugs -- designed to block the cox-2 enzyme and halt production of hormones that swell joints and cause pain in people with arthritis -- also stop an enzyme called cox-1 from producing blood-thinning agents. This results in a greater risk of blood clots, the news service reported.

The researchers said their findings are significant because they may lead to the development of cox-2 inhibitors that do not increase the risk of heart attack and stroke.

The findings were published in the Federation of American Societies for Experimental Biology Journal.

More information
For more on with juvenile rheumatoid arthritis, visit the U.S. National Library of Medicine.

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