December 05, 2006
FDA panel backs Celebrex to treat juvenile RA
An FDA advisory panel recommended that Pfizer’s Celebrex be approved to treat rheumatoid arthritis (RA) in children.
The panel of outside experts voted 15-1 in favor of using Celebrex in juvenile patients with RA, suggesting adverse events are closely monitored over the long term. The FDA is not required to follow the panel’s advice but usually does so.
Celebrex has faced concerns over its potential to increase heart risks among patients ever since the 2004 withdrawal of Merck’s Vioxx and Pfizer’s Bextra.
Following the Vioxx withdrawal, Pfizer continued to sell Celebrex and changed its warning label to include information about potential cardiovascular risks.
Celebrex is currently approved for the treatment of RA in adult patients.
Approximately 30,000 to 60,000 children in the US suffer from RA.