Celebrex Approved for Children

Christina Cole

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Federal approval has been granted to Pfizer Inc. to market the painkiller Celebrex as treatment for thousands of children that suffer with a devastating form of arthritis. The approval allows the New York company to promote the drug for juvenile rheumatoid arthritis in patients that are two years of age and older. The drug is already used off-label by many doctors as the treatment for the disease, which affects as many as 60,000 children in the United States.

Juvenile Rheumatoid Arthritis is often a devastating disease, said Dr. Steven Galson, director of the FDA's Center for Dug Evaluation and Research. While there are other drugs approved for treatment of this disorder, some children may experience intolerable side effects. Celebrex will be needed as an additional treatment option for children.

The decision comes after FDA advisers recommended Nov. 29 the drug as an effective but not necessarily safe treatment for the autoimmune disease, but said that its benefits still outweigh any risks. The FDA said it would require Pfizer to continue studying the safety of the drug in children, including its long-term effect on the kidneys, blood pressure and heart.

Celebrex is the only member of the class of drugs that included Vioxx and Bextra not to have been withdrawn from the market over concerns they elevate the risk of heart attacks and strokes in adults.

An earlier FDA review questioned the cardiovascular risks of long-term use of the drug in children.