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FDA NEWS RELEASE
FOR IMMEDIATE RELEASE
Celebrex Approved to Treat Juvenile Rheumatoid Arthritis
The U.S. Food and Drug Administration (FDA) today approved Celebrex (celecoxib) for a new use – the relief of the signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) in patients two years of age and older. Today's approval follows the November 29 meeting of FDA's Arthritis Advisory Committee, in which the committee voted 15 to 1 in favor of approval of this product.
JRA is an autoimmune disease that affects approximately 30,000 to 60,000 children in the United States. The disease is associated with joint swelling, pain, decreased range of motion and abnormalities of growth and development. In some cases, systemic complications may occur including uveitis, a chronic inflammation of the eye. In severe, uncontrolled cases, permanent disability may occur due to progressive joint damage.
“JRA is often a devastating disease,” said Steven Galson, M.D., MPH, Director of FDA’s Center for Drug Evaluation and Research. “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.”
A 24-week study of Celebrex involving 242 patients between the ages of two and 17 years demonstrated its effectiveness in treating JRA. The most commonly reported side effects were 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 two years, in patients who weigh less than 22 pounds, or in patients showing signs of having “systemic onset JRA”, a more serious type of JRA associated with high fever and rash. Celebrex should be used only with caution in patients with systemic onset JRA due to the risk for serious adverse reactions, including abnormal clotting tests, which can be associated with the clinical condition known as disseminated intravascular coagulation (DIC). DIC is a serious condition in which the body's blood clotting mechanisms are activated throughout the body instead of being localized to an area of injury.
Safety and efficacy were not studied beyond six months, and experience with adults suggests the possibility of longer term cardiovascular problems. As part of the approval of Celebrex, the drug's manufacturer has agreed to conduct two Phase 4 postmarketing studies: a short-term controlled trial to evaluate high blood pressure, and a several-year registry study to further evaluate long-term safety issues, including renal toxicity, high blood pressure, and cardiovascular events.
Celebrex, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), was originally approved in l998 for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis in adults. Celebrex is manufactured by Pfizer Inc. of New York, NY.
For more information on Celebrex and COX-2 drugs, please see http://www.fda.gov/cder/drug/infopage/COX2/default.htm