FDA Advisory Committee Recommends Approval Of Celebrex For Use In Children

Main Category: Arthritis / Rheumatology
Also Included In: Pain / Anesthetics;  Pediatrics / Children's Health
Article Date: 04 Dec 2006 - 15:00 PDT

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An FDA advisory panel on Wednesday voted 15-1 to recommend approval of Pfizer's pain medication Celebrex for the treatment of rheumatoid arthritis in children, even though some panel members questioned the long-term safety of the drug, the Wall Street Journal reports (Kowsmann, Wall Street Journal, 11/30). On Tuesday, FDA said Pfizer might have to conduct additional studies of Celebrex before it could be approved for use in children. The drug, which is approved to treat arthritis in adults, is the only member of a class of medications called COX-2 inhibitors, which include Vioxx and Bextra, not to have been withdrawn from the market over concerns of increased risk for heart attacks and stroke. Pfizer this year requested FDA approval for Celebrex as a treatment for rheumatoid arthritis in children ages two and older. According to FDA, about 30,000 to 60,000 children in the U.S. have rheumatoid arthritis. Drugs approved to treat the condition include aspirin, ibuprofen and naproxen. The heart attack risk for children who take the drug is unknown (Kowsmann, Wall Street Journal, 11/29).

Panel Recommendation
The panel said it decided to recommend approval of the drug because new treatments are needed for juvenile rheumatoid arthritis and Celebrex has been shown to be an effective treatment (Wall Street Journal, 11/30). The panel recommended that Pfizer establish a patient registry to track for up to three decades health indicators like blood pressure and kidney function in children who take Celebrex. Panel members said the drug potentially places children at a higher risk of having a heart attack later in life (Henderson, Boston Globe, 11/30). Panel member Joan Bathon, a rheumatologist at Johns Hopkins University, said, "The [panel's] 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." Steven Romano, a vice president in Pfizer's worldwide medical division, said, "That's not unreasonable. But the important part, when they considered both safety and benefit, is the benefits outweighed the risks" (Bridges, AP/Newark Star-Ledger, 11/30). Panel member Eric Holmboe, vice president of the American Board of Internal Medicine, criticized Pfizer's proposal to monitor the drug's side effects through reports physicians file with FDA. He said a voluntary reporting system would be a "very weak instrument" for tracking long-term health effects of the drug (Boston Globe, 11/30).

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