Drug safety in children and adolescents (a) off-label use and safety of neuroleptic and antidepressive medication, (b) safety of psycho-stimulant therapy

Description

In paediatric populations, drugs are frequently prescribed off-label (not in accordance with the approved age range or indications). This is also true for psychotropic drugs. Studies found that up to 94% of all antipsychotics and up to 91% of all antidepressants are prescribed off-label for children and adolescents. It is known that antipsychotics can cause adverse events like extrapyramidal symptoms, metabolic disorders, and marked weight gain. The intake of antidepressants can lead to cardiovascular and metabolic disorders. Beyond that, some studies observed an association between the use of antidepressants and suicidal behaviour. Despite the risk of adverse events and despite the frequent off-label use in young patients, it is still unknown if off-label use entails a higher risk of adverse events than on-label use.
Therefore, the objective of this research project was to investigate the extent and also the risks of antipsychotic and antidepressant drug use in children and adolescents up to an age of 17 years. A further aim was to examine the cardiovascular risks of methylphenidate use, a psychostimulant which is often used for the treatment of patients with attention deficit hyperactivity disorder (ADHD).

Funding period

Begin:   November 2012
End:   October 2015

Sponsor

  • Federal Institute for Drugs and Medical Devices

Contact

Dr. rer. medic. Tania Schink

Selected project-related publications

    Articles with peer-review

  • Schröder C, Dörks M, Kollhorst B, Blenk T, Dittmann R, Garbe E, Riedel O. Outpatient antipsychotic drug use in children and adolescents in Germany between 2004 and 2011. European Child & Adolescent Psychiatry. 2017;26(4):413-420.
    https://doi.org/10.1007/s00787-016-0905-7
  • Schröder C, Dörks M, Kollhorst B, Blenk T, Dittmann R, Garbe E, Riedel O. Outpatient antidepressant drug use in children and adolescents in Germany between 2004 and 2011. Pharmacoepidemiology and Drug Safety. 2017;26(2):170-179.
    https://doi.org/10.1002/pds.4138

    • Presentations at scientific meetings/conferences

  • Schröder C, Scholle O, Riedel O. Using administrative data to examine extent and risks of psychotropic drug use in children and adolescents. Possibilities and limitations. Congress "Health - Exploring Complexity: An Interdisciplinary Systems Approach (HEC2016)." Joint Annual Meeting of the German Society for Medical Informatics, Biometry and Epidemiology (GMDS), the German Society for Epidemiology (DGEpi), the International Epidemiological Association - European Region (IEA-EEF) and the European Federation for Medical Informatics Association (EFMI), 28 August-2 September 2016, Munich. (Abstract published in: European Journal of Epidemiology. 2016;31(Suppl.1):S179)
  • Garbe E, Dörks M, Schröder C, Tahden M, Kollhorst B, Blenk T. Arzneimittelsicherheit bei Kindern und Jugendlichen - Off-Label Anwendung von Neuroleptika und Antidepressiva. 21. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie, 20.-21. November 2014, Bonn.