FDA Says Celebrex Okay For Children

On January 13, 2007, the U.S. Food and Drug Administration (FDA) approved Celebrex for use in kids older than two as a treatment for juvenile rheumatoid arthritis (JRA). It is 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.

Celebrex, a member of the controversial group of painkillers called cox-2 inhibitors, was previously 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.

The FDA made its decision based on the recommendation of an advisory panel, which found that the benefits of the painkiller for children outweighed the shortage of proof on its safety. The advisory 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. The panel strongly suggested 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.

Article References
FDA OKs Celebrex for Kids With Arthritis, site accessed on 1/14/07