Paediatric adverse drug reactions reported in Sweden from 1987 to 2001

Purpose To describe frequency, seriousness and recovery of the patient in reported suspected paediatric adverse drug reactions (ADRs) in Sweden using data from a nation-wide ADR reporting system. Methods Data from ADR reports submitted to the Swedish Medical Products Agency (MPA) were collected from the database SWEDIS and analysed for the period from 1987 to 2001. All reports with certain, probable or possible causality assessments referring to paediatric patients < 16 years of age were included. Results In 5771 children an ADR report was documented during the whole 15-year period in a paediatric population of about 1.7 million individuals. The annual reporting frequency was about 385 reports per year. The most frequently reported reactions were application site reaction (24%) followed by fever (12%) and exanthema (6.7%). The clearly most frequently reported group of drugs were the vaccines (63.8%) followed by antibiotics for systemic use (10.1%). The proportion of children that suffered from a serious ADR was 13.0% and that for drug related deaths 0.14%. Nine per cent of the children had not recovered at the time of reporting and 1% recovered with sequelae. A male overrepresentation was observed regarding the total number of reports. About two-third of the reports concerned outpatients less than 4 years of age. Conclusions In respect of the limited number of paediatric drug safety studies or availability of record-linkage databases, nation-wide reporting systems of ADRs represent a valuable hypothesis generating tool in evaluating the characteristics of ADRs occurring in the orphan paediatric population. Copyright (c) 2005 John Wiley & Sons, Ltd.