Pfizer Inc., the New York Company got the green signal from the FDA in promoting Celebrex painkiller for treating children with a distressing form of arthritis.
The drug already is used off-label by some doctors as a treatment for the disease, which affects up to 60,000 U.S. children.
Dr. Steven Galson, director of the Food and Drug Administration’s Center said,
‘While there are other medicines approved for the treatment of this disorder, for some children they may have limited effectiveness or cause intolerable side effects. Celebrex will be a needed additional treatment option for children.’
However, the FDA has advised Pfizer to continue studying the safety of the drug in children, including its long-term effect on the kidneys, blood pressure and heart.
