engleski

Adverse Drug Reactions in Children Reportedto Croatian Agency for Medicinal Productsand Medical Devices from 2005 to 2013

Background:Due to limited data from clinical trials in children and significantly different pharmacokinetic profile compared to adults, the data obtained by reporting of adverse drug reactions (ADRs) have been crucial for safe use of drugs in children. Aim:To identify characteristics of reports and the ADRs reporting trends in children.Methods:We performed a retrospective analysis of all ADRs related to children reported to HALMED from March 2005 to April 2013. Croatian national ADR database—VigiFlow (version 5.0) [1] was used as data source. Drugs and ADRs were listed according to ATC codes and Med-DRA classification. ADRs were analyzed for each year individually by age, gender, ATC classification, system organ classes (SOCs), seriousness, reporter qualification, drug and vaccines ratio ; and then mutually com-pared. Seriousness was assessed using CIOMS V and EMA’s Important Medical Events criteria. Results:Total number of reports in children was 2388 (23.1 % of allreported ADRs to HALMED), with decreasing tendency since 2008.80.9 % of reports were related to vaccines ; the peak (92.0 % ; in 2009) and

Adverse drug reactions, pediatric medication, Croatian national ADR database

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