United States of America. The Food and Drug Administration has approved celecoxib (Celebrex: Searle), a new product for the treatment of rheumatoid arthritis and osteoarthritis. Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that blocks production of prostaglandins by inhibiting the enzyme cyclooxygenase-2 (COX-2).
Although studies showed that celecoxib has a substantially lower risk of gastrointestinal ulcers, a known effect associated with other NSAIDs, additional studies will be needed to ascertain whether celecoxib actually causes fewer serious gastrointestinal complications than other NSAIDs. Until such studies have been performed, the drug labelling for celecoxib will include the standard warning for doctors and their patients about gastrointestinal ulceration, bleeding and perforation. The labelling 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. Celecoxib does not affect platelet aggregation, an effect associated with other NSAIDs which may increase the risk of bleeding complications in some patients. However, celecoxib does not appear to differ from other NSAIDs in its effects on the kidneys.
Reference: FDA Talk Paper T98-89 dated 31 December 1998.