To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Celebrex For Osteoarthritis And Rheumatoid Arthritis URL: http://www.pslgroup.com/dg/D8DA6.htm Doctor's Guide January 4, 1999
CHICAGO, IL -- Jan. 4, 1999 -- The United States Food and Drug Administration has approved G.D. Searle & Co.'s and Pfizer Inc.'s Celebrex (celecoxib) for relief of the signs and symptoms of osteoarthritis (OA) and adult rheumatoid arthritis (RA). Celebrex is an important treatment alternative for millions of people with arthritis. Celebrex was tested in clinical trials that involved over 13,000 patients and healthy volunteers enrolled in more than 50 different clinical studies in 23 countries world-wide. In clinical trials, Celebrex was shown to be as effective as the prescription-strength nonsteroidal anti-inflammatory drug (NSAID) naproxen in treating arthritis pain and inflammation. In OA patients, Celebrex improved pain, stiffness and patient functions, such as walking, bending and getting in and out of a car. Importantly, Celebrex was associated with significantly fewer upper gastrointestinal (GI) ulcers than both naproxen and another widely-used arthritis medication, ibuprofen. Celebrex was designed using advanced molecular technology. Scientists believe that Celebrex works by inhibiting an enzyme called COX-2, which plays a role in pain and inflammation. However, Celebrex, at therapeutic doses, does not inhibit the COX-1 enzyme, which helps maintain the normal stomach lining. NSAIDs in general inhibit both COX enzymes, so they treat pain and inflammation but may damage the stomach lining, potentially leading to ulcers in some patients. Celebrex, which received priority review from the FDA, will be available by prescription in early 1999. The recommended therapeutic dose of Celebrex for OA is 200 mg daily administered as a single dose or 100 mg twice daily. For RA, the recommended therapeutic dose is 100 mg to 200 mg, twice daily. Many of the approximately 40 million Americans with arthritis use the currently available NSAIDs. Use of these medications may lead to stomach ulcers and other serious complications, such as GI bleeding or perforation. In fact, a recent study estimates that these complications cause 107,000 hospitalisations and 16,500 deaths each year in the United States. Arthritis is a chronic condition characterised by pain and inflammation of the joints (such as the knees, hips, fingers, feet, spine and shoulders). The most common type of arthritis, osteoarthritis, is a degenerative joint disease in which cartilage that covers the ends of the bones in the joint deteriorates, causing pain and loss of movement. Rheumatoid arthritis is an autoimmune disease in which the joint lining becomes inflamed as part of excessive immune system activity. Rheumatoid arthritis often results in destruction of the joint, pain and disfigurement, and limits the normal range of motion of the affected joint. Arthritis is estimated to cost the U.S. economy $65 billion per year in medical care and lost wages. Annual costs in the U.S. for hospitalisations resulting from serious NSAID side effects exceed $1 billion. In clinical studies, the most common GI side effects of Celebrex were dyspepsia, diarrhea and abdominal pain. Discontinuation due to each of these side effects was less than one percent. Patients who have a known allergic reaction to celecoxib, sulfonamides, aspirin or NSAIDs should not use Celebrex. Although Celebrex has a low potential for stomach ulcers, serious GI tract ulcerations can occur without warning symptoms. Physicians and patients should remain alert for signs and symptoms of GI bleeding. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.