PEM report number 9. Omeprazole

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Abstract
Patients (16,204) who had been treated with omeprazole by general practitioners in England between June 1989 and June 1990 have been studied by Prescription‐Event Monitoring (PEM). The pattern of events recorded during the six months following each patient's initial prescription has been compared individually with four other drugs used for similar indications and studied by the same method — cisapride, misoprostol, famotidine and nizatidine — and with pooled data on these and other unrelated drugs.Omeprazole had been prescribed most frequently for oesophageal reflux, oesophagitis, hiatus hernia and peptic ulcer or its complications. Seventy per cent of patients used a daily dose of 20 mg and 26% used 40 mg. Where efficacy had been reported, 81% of the patients were said to have benefited.A comparison of events recorded during the first month with those recorded with other drugs produced no noteworthy ‘signals’. Diarrhoea and nausea or vomiting were the only events which produced a rate‐ratio of more than three when the rate during the first month was compared to that during months two to six. These events were probably more related to the indication than the treatment. No serious hazards were identified and no deaths were attributable to omeprazole.

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