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

Purpose - Soon after the introduction of the proton pump inhibitor, lansopr azole, a 4-year observational follow-up study was started to evaluate the s afety of this drug in naturally-occurring groups of patients in The Netherl ands. Results of this study were compared with clinical trial data and the limited published data from observational studies. Methods - A prospective, observational study in which patients with a new e pisode 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 - A total of 805 general practitioners (GPs) and 266 specialists pr ovided 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 a nd frequency of reported adverse events was consistent with results from cl inical 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 a dverse events. Furthermore, no lansoprazole-related unlabelled adverse even ts of clinical significance were recorded. Conclusions - Although the patterns of use of lansoprazole in daily practic e deviated to some extent from the diagnoses in the information leaflet, la nsoprazole was found to have a highly acceptable safety profile in this lar ge naturally-occurring group of users. Reporting rates were higher soon aft er introduction of lansoprazole before falling to a lower stable level. Cop yright (C) 2000 John Wiley & Sons, Ltd.