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Safety profile of rofecoxib as used in general practice in England: results of a prescription-event monitoring study by Deborah Layton; Jane Riley; Lynda V. Wilton; Saad A. W. Shakir is a Medicine article available to read on EtoBox.

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**Aims** A postmarketing Prescription‐Event Monitoring study was undertaken to monitor the safety of rofecoxib, a cyclo‐oxygenase (COX)‐2 selective inhibitor prescribed in primary care in England. **Methods** Questionnaires requesting clinical event data were sent to prescribing physicians between February and November 2000, and the data analysed for all events. **Results** There were 15 268 patients identified, mean age 62 years, 67% female. The commonest specified indication was osteoarthritis (24%). Dyspepsia and nausea were the most frequently reported adverse events. A history of dyspeptic or upper gastrointestinal (GI) conditions, recent use of other nonsteroidal anti‐inflammatory drugs (NSAIDs), use of selected concomitant gastroirritant drugs (NSAIDs, aspirin, anticoagulants, antiplatelet drugs), or gastroprotective drugs (misoprostol, antacids, proton‐pump inhibitors, histamine‐2 antagonists), and age (≥ 65 years) modified the risk of having minor GI events. During treatment or within 1 month of stopping, 110 serious GI events were reported (including 76 upper GI bleeds/peptic ulcers, one perforated colon), 101 thromboembolic events, three reports of acute renal failure, o

Who reads Safety profile of rofecoxib as used in general practice in England: results of a prescription-event monitoring study?

Author

Deborah Layton; Jane Riley; Lynda V. Wilton; Saad A. W. Shakir

Publisher

John Wiley and Sons; Wiley (Blackwell Publishing); Blackwell Publishing Inc.; Wiley; Research Square (ISSN 0306-5251)

Published

2003

Language

EN

Field

Medicine (Health Sciences)