The FDA's advisory panel had recommended the painkiller for this use back in November of 2006, with a vote of 15 to 1. The one opposing vote cited the lack of long-term, established data tracking the drug's safety for use in children. However, the 15 votes approving the recommendation claimed the risks involved outweighed the benefits.
A 24-week study was conducted on 242 children between the ages of two and 17 years, in which Celebrex and a placebo were used to determine the effectiveness of the drug in treating JRA.
Although there were commonly found side effects, including cough and cold symptoms, nausea, diarrhea, headaches and fever, these were not substantial enough to stop the approval process.
The study did not include those children younger than two years of age.
Also not included in the study were children who have a more serious form of JRA, known as "systemic onset JRA," which is associated with high fevers and rashes. The FDA cautions medical practitioners to only utilize Celebrex with caution in these cases, due to the risk of possible serious and harmful reactions.
The FDA approval includes an agreement with the drug manufacturer to continue conducting further long-term studies on the effectiveness and safety of Celebrex in the use of children with JRA.
Prior experience with adults has suggested that long-term cardiovascular problems may possibly exist from using this drug.
The autoimmune disease, JRA, currently affects approximately 30,000 to 60,000 children in the U.S., according to the FDA. Symptoms include pain associated with joint swelling, a decrease range of motion, and abnormal growth and development. Some patients may even have develop chronic eye disease and progressive joint damage leading to permanent disability from JRA.
According to the director of the FDA's Center for Drug Evaluation and Research, Dr. Steven Galson, "JRA is often a devastating disease. 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."
