Losartan: a study of pharmacovigilance data on 14 522 patients

The objective of this study was to undertake a postmarketing safety surveil lance study of losartan, the first specific angiotensin-ll receptor antagon ist to be marketed in England. It is a non-interventional observational coh ort study using the technique of prescription-event monitoring. Subjects wh o took part in the study were from 14 522 patients treated by general pract itioners in England. We recorded adverse drug reactions, adverse events, re asons for stopping the drug, pregnancies and deaths. The results were that general practitioners considered the drug to have been effective in 85.9% o f the patients evaluated for effectiveness. Dizziness, malaise, lassitude, nausea, cough and headache were among the most frequently reported adverse drug reactions, reasons for stopping the drug and events of highest inciden ce density. None of the deaths that occurred were attributed to losartan an d no serious unexpected adverse reactions or interactions were identified. In conclusion losartan has an acceptable safety profile and the study confi rms the safety information given in the current Summary of Product characte ristics for losartan.