December 31, 1998

FDA has approved Celebrex (Celecoxib), a new product to treat rheumatoid arthritis and osteo-arthritis. Celebrex is an NSAID or non-steroidal anti-inflammatory drug that blocks production of prostaglandins by inhibiting the enzyme cyclooxygenase-2 (Cox-2). The following may be used to respond to questions:

Arthritis affects millions of Americans -- more than three million with rheumatoid arthritis, and 16 million with osteoarthritis, the most common form of arthritis affecting the elderly. Both cause painful inflammation and joint deterioration.

Unlike other NSAIDS, Celebrex does not inhibit the enzyme cyclooxygenase-1 or COX-1. Inhibition of COX-1 is believed to contribute to some of the adverse effects of NSAIDS, including upper gastrointestinal ulcers. It is therefore hoped that Celebrex will have safety advantages compared to other NSAID products. Additional studies and post-marketing experience will add substantially to the understanding of how the overall risks and benefits of Celebrex compare with those of other NSAID products.

Celebrex was found to be an effective arthritis treatment in placebo and active-controlled clinical trials that enrolled 2100 patients with rheumatoid arthritis and 4200 patients with osteoarthritis.

Celebrex was compared to other NSAID products in several of these clinical trials by using endoscopes (a device to examine organs of the gastrointestinal tract) to determine the incidence of stomach and upper intestinal ulcerations following the use of these products. These studies showed that patients taking Celebrex had a substantially lower risk of ulcers detected by endoscopy over the study period of 12 to 24 weeks compared to patients who took other NSAIDS.

However, NSAID products can cause a range of gastrointestinal problems, and patients with endoscopic ulcers may often recover without special treatment and without experiencing any serious symptoms or complications. Therefore, additional studies in many thousands of patients would be needed to see whether Celebrex actually causes fewer serious gastrointestinal complications than other NSAID products. Until such studies are done, the drug labeling for Celebrex will include the standard warning for doctors and their patients about the risks associated with all NSAIDS, including risks of GI ulceration, bleeding and perforation. The labeling advises patients taking these drugs to be alert for ulceration and bleeding that can occur with or without warning. Patients should promptly report signs and symptoms of gastrointestinal ulceration or bleeding, skin rash, unexplained weight gain, or swelling to their physicians.

In addition, Celebrex does not affect platelet aggregation (clumping) an important part of the blood clotting process. Many other NSAID products can interfere with this platelet function, which may increase the risk of bleeding complications in some patients. However, Celebrex does not appear to be different from other NSAIDS in its effects on the kidneys.

Celebrex is manufactured by Searle of Chicago, Illinois

FDA TALK PAPER
Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

   Inhouse Drugstore Europe