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| |  FDA Approves Celebrex (Celecoxib) for Acute Pain Relief PEAPACK, NJ -- October 22, 2001 -- Pharmacia Corporation and Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the use of Celebrex® (celecoxib capsules) for the effective management of acute pain and primary dysmenorrhea (menstrual pain) in adults. Importantly, this new indication provides patients the benefit of being able to take an additional dose if needed for individualized relief of acute pain. "With this approval, Celebrex has the broadest range of approved indications of any COX-2 specific inhibitor," said Carrie Cox, President of Pharmacia's Global Prescription Business. "We are pleased with the Agency's action because it reaffirms the efficacy and safety profile of Celebrex and also allows Celebrex to effectively compete in the large acute pain market, " she added. Celebrex is the only COX-2 specific inhibitor approved to date for the relief of pain and inflammation of osteoarthritis (OA) and adult rheumatoid arthritis (RA). In addition, it is also approved to reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP) - a rare and devastating genetic disease that may result in colorectal cancer - as an adjunct to usual care. The FDA approval followed a review of data from the clinical studies of more than 1,700 patients with post oral-surgery pain, musculo-skeletal pain, post-orthopaedic surgery pain or primary dysmenorrhea where patients rated their pain as moderate to severe. This approval provides doctors with an effective and well-tolerated addition to the management of pain in Latin America, South Africa and the United States. Celebrex is the only COX-2 specific inhibitor approved for both osteoarthritis (OA) and adult rheumatoid arthritis (RA) and for the management of acute pain. The recommended dose for OA is 200 mg daily and for RA, 100 mg to 200 mg twice per day. The recommended dose for acute pain is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed. Celebrex should not be taken by patients who have aspirin-sensitive asthma or allergic reactions to aspirin or other arthritis medicines or certain sulfa drugs called sulfonamides, or who are in their third trimester of pregnancy. As with all non-steroidal anti-inflammatories (NSAIDs), serious gastrointestinal (GI) tract ulcerations can occur without warning symptoms. Physicians and patients should remain alert to the signs and symptoms of GI bleeding. Celebrex does not affect platelet function and therefore should not be used for cardiovascular prophylaxis. As with all NSAIDs, Celebrex should be used with caution in patients with fluid retention, hypertension, or heart failure. In overall clinical studies the most common side effects of Celebrex were dyspepsia, diarrhea and abdominal pain, which were generally mild to moderate. There have been infrequent post-marketing reports of increases in prothrombin time, sometimes associated with bleeding events, predominantly in the elderly. Anticoagulant activity should be monitored when therapy with Celebrex is initiated or changed in patients taking warfarin, particularly in the first few days. SOURCE: Pharmacia Corporation Related Links: Celebrex (celecoxib capsules), Pfizer Inc. and Pharmacia Corporation.
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