6 A multicenter pharmacovigilance study on antidepressant and antipsychotic use in children and adolescents in daily clinical practice

Introduction To learn more about the prescription patterns and safety of antidepressants and antipsychotics in children and adolescents in daily clinical practice a multicenter clinical pharmacovigilance trial (‘TDM-VIGIL-study’), funded by the Federal Institute of Drugs and Medical Devices (BfArM), was performed.

Methods Children and adolescents treated on- and off-label with antidepressants and antipsychotics for various psychiatric disorders by 18 centers in Germany, Austria and Switzerland were prospectively followed between October 2014 and December 2018. The follow-up included standardized assessments of side effects and serum concentrations (therapeutic drug monitoring/TDM); an internet-based patient registry was used for data collection.

Results 710 children and adolescents, mean age 14.6 years, 66.6 % female, were observed 167 days on average. 25.5.% were suicidal at enrollment. 76.9 % received antidepressants, 47.8 % antipsychotics. About 70 % had at least one medication episode under off-label conditions. Adverse drug reactions (ARDs) occurred in more than 40 % of the patients, but were mostly rated as mild. All serious ADRs (8,7 %) developed favorably and proportions of serious ADRs were not increased due to off-label use.

Conclusion Our results confirm the chosen method of standardized patient and TDM as valuable approach of post-marketing surveillance.

Publication History

Article published online:
30 April 2020