Safety review in 10,008 users of lansoprazole in daily practice

Purpose—Soon after the introduction of the proton pump inhibitor, lansoprazole, a 4‐year observational follow‐up study was started to evaluate the safety of this drug in naturally‐occurring groups of patients in The Netherlands. Results of this study were compared with clinical trial data and the limited published data from observational studies. Methods— prospective, observational study in which patients with a new episode of lansoprazole use were followed during the medication period for a maximum of 2 years. All (adverse) events during use were documented by the prescriber, irrespective of possible association with lansoprazole therapy. Results— total of 805 general practitioners (GPs) and 266 specialists provided a total of 10,008 lansoprazole users with a broad range of diagnoses. Of all patients, 17.4% reported one or more adverse events. The profile and frequency of reported adverse events was consistent with results from clinical trials and other observational studies. The most frequently reported adverse events were diarrhoea, headache, nausea, skin disorders, dizziness and generalized abdominal pain/cramps. There was no new evidence of rare adverse events. Furthermore, no lansoprazole‐related unlabelled adverse events of clinical significance were recorded. Conclusions— Although the patterns of use of lansoprazole in daily practice deviated to some extent from the diagnoses in the information leaflet, lansoprazole was found to have a highly acceptable safety profile in this large naturally‐occurring group of users. Reporting rates were higher soon after introduction of lansoprazole before falling to a lower stable level. Copyright © 2000 John Wiley & Sons, Ltd.