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New Arthritis Drug May Have Fewer Side Effects. (Celebrex) FDA Consumer v33, n2 (March, 1999):3 (1 pages).COPYRIGHT 1999 U.S. Department of Health and Human Services

Arthritis patients now have another weapon in their fight against the painful and deteriorating effects of this disease: a new nonsteroidal anti-inflammatory drug that may not have the same side effects as other NSAIDs.

Celebrex (celecoxib), approved by FDA in December for rheumatoid arthritis and osteoarthritis, was found in several studies to substantially lower the risk of stomach and upper intestinal ulcers compared with other NSAIDs. However, FDA believes that additional studies are needed to see how the overall risks of Celebrex actually compare with those of other NSAIDs. Until such studies are done, FDA is requiring the drug's labeling to include the standard warning about the risks of gastrointestinal ulcers, bleeding and perforation associated with all NSAIDs.

The drug's labeling will advise patients taking Celebrex to be alert for signs of ulcers and bleeding, which can occur without warning, and to promptly report to their doctors such signs or symptoms as skin rash, unexplained weight gain, and swelling.

Another potential advantage of Celebrex is that it does not affect platelet aggregation (clumping), an important part of the blood clotting process. Many other NSAIDs can interfere with this platelet function, increasing the risk of bleeding complications in some patients. Celebrex is made by G.D. Searle & Co., Chicago.

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