scholarly journals Extent and Risks of Antipsychotic Off-Label Use in Children and Adolescents in Germany Between 2004 and 2011

2017 ◽  
Vol 27 (9) ◽  
pp. 806-813 ◽  
Author(s):  
Carsten Schröder ◽  
Michael Dörks ◽  
Bianca Kollhorst ◽  
Tilo Blenk ◽  
Ralf W. Dittmann ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Off-Label Use of Clozapine in Children and Adolescents—A Literature Review

2019 ◽  
Vol 26 (3) ◽  
pp. e406-e416 ◽  
Author(s):  
Vivekananda Rachamallu ◽  
Benjamin W. Elberson ◽  
Emily Vutam ◽  
Manish Aligeti
Keyword(s):  
Literature Review ◽  
Children And Adolescents ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

scholarly journals Off-Label Use of Bedaquiline in Children and Adolescents with Multidrug-Resistant Tuberculosis

2017 ◽  
Vol 23 (10) ◽  
pp. 1711-1713 ◽  
Author(s):  
Jay Achar ◽  
Cathy Hewison ◽  
Ana P. Cavalheiro ◽  
Alena Skrahina ◽  
Junia Cajazeiro ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Multidrug Resistant ◽  
Off Label Use ◽  
Off Label ◽  
Resistant Tuberculosis ◽  
Multidrug Resistant Tuberculosis ◽  
Label Use

scholarly journals National trends in off-label use of atypical antipsychotics in children and adolescents in the United States

Medicine ◽  
2016 ◽  
Vol 95 (23) ◽  
pp. e3784 ◽  
Author(s):  
Minji Sohn ◽  
Daniela C. Moga ◽  
Karen Blumenschein ◽  
Jeffery Talbert
Keyword(s):  
United States ◽  
Children And Adolescents ◽  
Atypical Antipsychotics ◽  
The United States ◽  
Off Label Use ◽  
Off Label ◽  
National Trends ◽  
Label Use

scholarly journals Extent and risks of antidepressant off-label use in children and adolescents in Germany between 2004 and 2011

2017 ◽  
Vol 26 (11) ◽  
pp. 1395-1402 ◽  
Author(s):  
Carsten Schröder ◽  
Michael Dörks ◽  
Bianca Kollhorst ◽  
Tilo Blenk ◽  
Ralf W. Dittmann ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

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

PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0247446
Author(s):  
Sarah Leitzen ◽  
Diana Dubrall ◽  
Irmgard Toni ◽  
Julia Stingl ◽  
Maike Schulz ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Adverse Drug Reactions ◽  
Healthcare Professionals ◽  
Annual Number ◽  
Age Group ◽  
Off Label Use ◽  
Drug Reactions ◽  
Off Label ◽  
Time Period ◽  
Label Use

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 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.

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