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News 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.

Adverse events were similar to those reported in arthritis trials. Intestinal anastomotic ulceration, the only new adverse event in the FAP trial, was seen in three of 58 patients (one at 100 mg twice daily and two at 400 mg twice daily).

Treatment with celecoxib for FAP has not been shown to reduce the risk of gastrointestinal cancer or the need for prophylactic colectomy or other FAP-related surgery.

Written inquiries may be directed to Jane E. Henney, MD, Commissioner of Food and Drugs, HF-1, Room 14-71, 5600 Fishers Ln, Rockville, MD 20857.