1 Social and Clinical Pharmacy, Department of Pharmacy, Faculty of Health and Medical Sciences, Københavns Universitet2 Faculty of Health Sciences, Institute of Public Health, University of Southern Denmark, J.B. Winsløws Vej 19, 5000, Odense, Denmark, firstname.lastname@example.org Social and Clinical Pharmacy, Department of Pharmacy, Faculty of Health and Medical Sciences, Københavns Universitet
Background Information about medicines safety in children is very limited. Consumer adverse drug reaction (ADR) reports can provide information about serious and unknown ADRs from medicine use in children. Objective To characterize ADRs in children reported by consumers in Europe from 2007 to 2011. Methods We analysed ADRs reported to the European ADR database, EudraVigilance (EV) for individuals from birth to 17 years. Data were characterized with respect to age and sex of the child, type of ADR (system organ class and preferred term), seriousness and suspected medicines (anatomical therapeutic chemical classification system level 1 and 5). Results In total, 240 ADR reports corresponding to 670 ADRs were identified. The relatively largest share of ADRs were reported for infants below 1 year followed by teenagers, and 60 % of all ADRs were reported for girls. The majority of ADRs reported were of the general type (20 %) and nervous system disorders (15 %). The largest share of serious ADRs was of the type nervous system disorders (17 % of all serious). Three cases of death were reported. Vaccines and anti-infectives for systemic use contributed to 30 % of ADRs, antineoplastic and immunomodulating agents for 23 % and sex hormones for 13 %. Conclusion Only few paediatric ADR consumer reports were found in EudraVigilance. Many of these ADRs were serious, and fatal cases were reported, however also nonserious reports were present. The findings indicate that consumer reports may be of value in paediatric ADR signal detection.
International Journal of Clinical Pharmacy, 2014, Vol 36, Issue 2, p. 295-302