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

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Layton D, Riley J, Wilton LV, Shakir SA.

Drug Safety Research Unit, Bursledon Hall, Southampton, UK.

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, one each of Stevens-Johnson syndrome, severe anaphylaxis and angio-oedema.

CONCLUSIONS: Doctors should continue to prescribe NSAIDs including COX-2 selective inhibitors with caution.

Br J Clin Pharmacol 2003 Feb;55(2):166-74

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