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FDA Panel Recommends Approval of Celebrex for Children Despite Safety Concerns

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An FDA Advisory Committee has recommended that Pfizer be allowed to market Celebrex to children ages 2 and older who suffer from Juvenile Rheumatoid Arthritis (JRA). The panel voted 15-1 that the drug was an effective treatment and that its benefits outweighed its risks. The panel members split on the issue of safety, voting 8-7 (with one abstention) that available data does not demonstrate safety. The panel strongly recommends that the safety of Celebrex in children be monitored for 10-20 years, possibly by creating a registry of patients. Panel member Dr. Joan Bathon, rheumatologist at Johns Hopkins, said, “The feeling was short-term efficacy looked good and short-term safety was not an issue. Long-term safety is totally unknown and needs to be known.” The FDA is not required to take the advice of its expert panels, but it usually does.