FDA Gives Nod to Celebrex for Juvenile Rheumatoid Arthritis
Manufacturer agrees to key post-marketing studies to better assess long-term safety
MONDAY, Dec. 18 (HealthDay News) -- The U.S. Food and Drug Administration has approved Celebrex (celecoxib) to relieve the signs and symptoms of juvenile rheumatoid arthritis in patients 2 years of age and older. Since questions remain about the drug's long-term safety in pediatric patients, Celebrex manufacturer Pfizer, Inc. agreed to conduct two pivotal phase 4 post-marketing studies including a short-term controlled trial to evaluate high blood pressure, and a several-year registry study to further evaluate long-term safety issues.
The FDA based their approval on a 24-week study of 242 juvenile rheumatoid arthritis patients between the ages of 2 and 17 years that demonstrated Celebrex's effectiveness. Common side effects included cough, cold, upper respiratory tract infection, abdominal pain, headache, fever, nausea, diarrhea and vomiting.
Celebrex has not been studied in patients under the age of 2 years, in patients who weigh less than 22 pounds, or in patients showing signs of having "systemic onset" juvenile rheumatoid arthritis.
"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," Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research in Rockville, Md., said in a statement.