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European CHMP concludes review of celecoxib in familial adenomatous polyposis - NeLM European CHMP concludes review of celecoxib in familial adenomatous polyposis The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has finalised its review on the use of celecoxib in the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP).The review was initiated because of concerns that celecoxib may be used off-label in the FAP indication following the withdrawal of Onsenal. The CHMP looked at the available data on the use of celecoxib in FAP patients, including the results from the main study that supported the marketing authorisation for Onsenal, an ongoing study with celecoxib, post-marketing safety data and data from the published literature. The Committee concluded that the benefit of celecoxib in FAP patients had not been sufficiently demonstrated and did not outweigh the increased risk of cardiovascular and gastrointestinal side effects, which would result from high dose and long-term treatment used in FAP patients. Celebrex: 1250 user reviews - DailyStrength Join | Help | Sign In 0-9 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Celecoxib is a non-steroidal anti-inflammatory drug (NSAID) used in the treatment of osteoarthritis, rheumatoid arthritis, acute pain, painful menstruation and menstrual symptoms, and to reduce numbers of colon and rectum polyps in patients with familial adenomatous polyposis. more at Wikipedia Review of the selective COX-2 inhibitors celecoxib and rofecoxib: focus on clinical aspects | Canadian Journal of Emergency MedicinePharmacotherapeutic Specialist, Internal Medicine, Pharmaceutical Sciences Clinical Service Unit, Vancouver Hospital and Health Sciences Centre, Vancouver, BC; Clinical Assistant Professor of Pharmacy, University of British Columbia, Vancouver; Coordinator, Advanced Pharmacotherapeutics, Doctor of Pharmacy Program, UBC Chair, UBC Clinical Research Ethics Board; Publishing Editor, The Journal of Informed PharmacotherapyThe selective cyclooxygenase-2 (COX-2) inhibitors celecoxib and rofecoxib were designed to have similar efficacy but less gastrointestinal toxicity than traditional nonsteroidal anti-inflammatory drugs (NSAIDs). Their efficacy has been demonstrated in the treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, postoperative dental pain and dysmenorrhea. These agents produce fewer endoscopic ulcers, symptomatic ulcers and gastrointestinal bleeds than traditional NSAIDs; although the absolute benefit is small and the gastropreserving effect is negated by concurrent use of low-dose aspirin for cardiovascular risk reduction. Nephrotoxicity and hyptertension remain concerns with COX-2 inhibitors, as they are with traditional NSAIDs. COX-2 inhibitors may be safe alternatives to traditional NSAIDs for patients with aspirin-sensitive asthma.Drug utilization review of celecoxib in Ontario Skip Navigation Pharmacoepidemiology and Pharmacoeconomics Research Unit, Centre hospitalier de l�Universite de Montreal, Montreal, Cyclooxygenase (COX)-2-specific inhibitors were developed to circumvent the gastrointestinal toxicity of non-specific non-steroidal anti-inflammatory drugs while maintaining efficacy.
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