Lay summary: The Pharmacovigilance of Pantoprazole. The Results of Postmarketing Surveillance on 11,541 Patients in England

Objective

Pantoprazole was the third proton pump inhibitor launched in the UK. Proton pump inhibitors work by reducing the amount of acid produced by the stomach and are used to treat conditions such as stomach ulcers, acid reflux and heartburn. The aim was of this was study to monitor the safety of pantoprazole as used in general practice in the period following the launch of this drug in November 1996. Prescription-event monitoring (PEM) provides data on a large number of patients in 'real life' settings.

Methods

Patients prescribed pantoprazole were identified from dispensed prescriptions written by general practitioners (GPs) in England. After an interval of 6 months, a questionnaire was sent by the DSRU to the prescribing GP. This requested information on all medical events that had occurred since pantoprazole was prescribed. A medical event is defined as any new illness, or change in an existing illness, regardless of whether or not it was thought to be related to treatment. The information received was then analysed and used to monitor the safety of pantoprazole.

Results

Information was collected for 11,541 patients. The most common conditions for which pantoprazole was prescribed were heartburn (23%) and dyspepsia (17%). 82% of GPs that expressed an opinion said that they thought pantoprazole had been effective for their patient. GPs reported 107 events as suspected adverse drug reactions (i.e. the GP suspected that the event had been caused by pantoprazole). The most frequent reason given for stopping treatment with pantoprazole was diarrhoea (106 patients), and this was also the most frequently reported adverse event.

Conclusion

This study confirms the safety profile of pantoprazole. The commonest adverse events found in this study were already recognised as side-effects in the product information.