Analysis of the reporting of adverse drug reactions in children and adolescents in Germany in the time period from 2000 to 2019

Sarah Leitzen*, Diana Dubrall, Irmgard Toni, Julia Stingl, Maike Schulz, Matthias Schmid, Antje Neubert, Bernhardt Sachs

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The objective of this study was to analyse reports on adverse drug reactions (ADRs) from Germany in the particularly vulnerable patient group of children and adolescents. Reporting characteristics, demographic parameters and off-label use were examined among others. The ratio of ADR reports per number of German inhabitants and the ratio of ADR reports per number of German inhabitants exposed to drugs were calculated and compared. These parameters were examined to derive trends in reporting of ADRs. 20,854 spontaneous ADR reports for the age group 0-17 years were identified in the European ADR database Eudra- Vigilance for the time period 01.01.2000-28.02.2019 and analysed with regard to the aforementioned criteria. 86.5% (18,036/20,854) of the ADR reports originated from Healthcare Professionals and 12.2% (2,546/20,854) from non-Healthcare Professionals. 74.4% (15,522/20,854) of the ADR reports were classified as serious. The proportion of ADR reports per age group was 11.8% (0-1 month), 11.0% (2 months-1 year), 7.4% (2-3 years), 9.3% (4-6 years), 25.8% (7-12 years), and 34.8% (13-17 years) years, respectively. Male sex slightly dominated (51.2% vs. 44.8% females). Only 3.5% of the ADR reports reported off-label use. The annual number of ADR reports increased since 2000, even if set in context with the number of inhabitants and assumed drug-exposed inhabitants. The pediatric population declined in the study period which argues against its prominent role for the increase in the total number of ADR reports. Instead, among others, changes in reporting obligations may apply. The high proportion of serious ADR reports underlines the importance of pediatric drug safety.

TidsskriftPLOS ONE
Udgave nummer3
Antal sider18
StatusUdgivet - 3. mar. 2021

Bibliografisk note

Funding Information:
Sarah Leitzen received funding from the KiDSafe study. The Project KiDSafe is funded by the German innovation fund of the Federal Joint Committee (G-BA) under the fund mark 01NVF16021. Matthias Schmid and Diana Dubrall received funding from the Federal Institute for Drugs and Medical Devices (BfArM) own resources and the Institute for Medical Biometry, Informatics, and Epidemiology (IMBIE), University Hospital of Bonn (V-16703/68502/2016-2020). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Publisher Copyright:
© 2021 Leitzen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Copyright 2021 Elsevier B.V., All rights reserved.


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