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From the Food and Drug Administration
March 1, 2000

Celecoxib Indicated for FAP

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JAMA. 2000;283(9):1131. doi:10.1001/jama.283.9.1131-JFD00001-3-1

The FDA has approved celecoxib (Celebrex; G. D. Searle & Co, Chicago), an anti-inflamatory cyclooxygenase 2 inhibitor, as the first drug treatment for familial adenomatous polyposis (FAP). Celecoxib had been approved for treating osteoarthritis and rheumatoid arthritis. The new indication is for reduction in the number of adenomatous colorectal polyps in FAP, as an adjunct to endoscopy and surgery.

The accelerated approval was based on a study in 83 patients with FAP, of whom 58 had a prior colectomy and 25 had an intact colon. One area in the rectum and up to four areas in the colon were identified at baseline, and polyps were counted at baseline and after 6 months of treatment. The mean reduction in the number of polyps was 28% for 400 mg of celecoxib twice daily, 12% for 100 mg twice daily, and 5% for placebo.

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