The pharmacovigilance of pantoprazole: the results of postmarketing surveillance on 11 541 patients in England.

objectiveTo conduct a postmarketing surveillance study involving patients treated with pantoprazole in general practice in the 6-month period following the launch of this drug in November 1996. Prescription-event monitoring (PEM) provides data on a large cohort of patients in 'real life' settings. The aim was to monitor the safety of pantoprazole as used in general practice. It was the third proton pump inhibitor launched in the UK.

methodsPatients were identified by data from dispensed prescriptions (FP10s) written by general practitioners (GPs) in England for pantoprazole. Green forms were posted to GPs approximately 6 months following the first prescription identified. GPs were asked to list events that occurred during and after treatment. The incidence density of each event was calculated, ranked and the difference between the incidence of each event in the first and subsequent months of exposure was tested by constructing confidence intervals.

resultsData were collected for 11 541 patients. The major indications for treatment were oesophageal reflux (22.7%) and dyspepsia (16.9%). Of GPs expressing an opinion, 81.9% reported pantoprazole to be effective. GPs reported 107 events as adverse drug reactions. The most frequent reason given for stopping was diarrhoea (106 patients), which corresponded with the adverse event with the highest incidence density.

conclusionThis PEM study has defined the reported safety profile of pantoprazole as used in general practice in England. The commonest adverse events found in this study have already been reported in the Summary of Product Characteristics.