The FDA ( Food and Drug Administration ) has approved Celebrex ( Celecoxib ) for a new use: the relief of the signs and symptoms of juvenile rheumatoid arthritis in patients two years of age and older.
Juvenile rheumatoid arthritis 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.
A 24-week study of Celebrex involving 242 patients between the ages of two and 17 years demonstrated its effectiveness in treating juvenile rheumatoid arthritis. 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 juvenile rheumatoid arthritis , a more serious type of juvenile rheumatoid arthritis associated with high fever and rash.
Celebrex should be used only with caution in patients with systemic onset juvenile rheumatoid arthritis 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.
Source: FDA, 2006