FDA Approves Celebrex for Treatment of Juvenile Arthritis

By Nathan Abbott

Published on January 11, 2007

The U.S. Food and Drug Administration (FDA) has approved Celebrex as treatment for juvenile rheumatoid arthritis in children over two years old, following the recommendation of an advisory panel. The agency decided that the potential benefits for the children outweigh the relative shortage of safety information. Juvenile rheumatoid arthritis causes painful joint swelling, and affects as many as 60,000 children in the U.S. The disease can also hinder growth and development.

The FDA noted that while there are other medicines available for treatment of the disorder, Celebrex will provide another alternative for patients who find limited efficacy in other drugs.

Celebrex has fared better than other COX-2 inhibitors, as both Bextra and Vioxx have been pulled from the market for health risk concerns after a link was shown between the drugs and an increased incidence of heart attack and stroke. Celebrex remains available to consumers, but carries a “black box” warning about the possible dangers.

The FDA will still require Pfizer to continue to study the safety of the drug’s use in children, including a short-term controlled trial to evaluate high blood pressure, and a long-term study to monitor renal toxicity, high blood pressure, and cardiovascular events.

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