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Juvenile Rheumatoid Arthritis

Controversial U.S. FDA panel approves drug for use by children

Published in Medical Letter on the CDC and FDA, January 7th, 2007

An FDA advisory panel's recommendation to allow Celebrex to be marketed for children suffering from juvenile rheumatoid arthritis (JRA) has some experts concerned over long-term health effects.

While the issue of short-term efficacy and safety did not seem a big issue with the FDA panel, long-term safety was a matter of concern.

The disease affects some 60,000 children nationally. Celebrex is a member of the COX2 inhibitor class of drugs that include Vioxx and Bextra, both pulled from the market by the FDA because of serious or fatal heart-related injuries or stroke associated with the drug.

According to Howard Coleman, CEO and...

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