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

ABSTRACT: 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 EudraVigilance 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 Professio

SUBMITTER: Leitzen S 

PROVIDER: S-EPMC7928460 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature