FDA Panel Recommends Approval of Celebrex for Juvenile Arthritis

GAITHERSBURG, Md. - An advisory panel to the FDA has voted in favor of approving Pfizer Inc.'s COX-2 inhibitor Celebrex for treating rheumatoid arthritis in children despite uncertainty about the drug's potential risks with long-term use.

On Nov. 29, the committee of outside doctors and other specialists unanimously determined that Celebrex is an effective treatment for juvenile rheumatoid arthritis, but voted 8-7, with one abstention, that available data did not clearly establish that the painkiller is safe for treating the disease.

Nonetheless, the panel decided 15-1 that the benefits of Celebrex outweigh the risks.

Members of the committee said it …