Celebrex® Infromative Articles Nightingale, Stuart L. Celecoxib for Arthritis
.(From the Food and Drug Administration) JAMA, The Journal of the American Medical Association v281, n9(March 3, 1999):786 (1 pages).
COPYRIGHT 1999 American Medical Association. All Rights Reserved. The FDA has approved celecoxib (Celebrex, GD Searle, Skokie, Ill) for relief of the signs and symptoms of osteoarthritis and
for relief of the signs and symptoms of rheumatoid arthritis in adults. Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) whose mechanism of action is believed to be due to inhibition of
prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2). At therapeutic doses in humans, it does not appear to inhibit COX-1 (believed by many to be important in the
gastrointestinal system). Upper gastrointestinal (GI) tract endoscopic evaluations were performed in more than 4500 arthritis patients who were enrolled in several controlled, randomized,
12-24 week trials. Celecoxib was associated with a statistically significantly lower incidence of endoscopic ulcers over the study period in three studies that included naproxen, in one study
that included ibuprofen, and in one of two studies that included diclofenac. The correlation between findings of endoscopic studies and the relative incidence of clinically serious upper GI
tract events that may be observed with different products has not been fully established. Serious clinically significant upper GI tract bleeding, although infrequent, has been observed in
patients receiving celecoxib. Additional prospective, long-term studies comparing the incidence of serious, clinically significant upper GI tract adverse events and postmarketing experience will
add substantially to the understanding of how the overall risks and benefits of celecoxib compare with those of other NSAID products. Patients should be informed about the signs and symptoms
of serious GI tract toxicity and the steps to take if they should experience them. Physicians and patients should remain alert for ulceration and bleeding, even in the absence of previous GI
tract symptoms. ORDER CELEBREX® ONLINE NOW! |
