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Despite the growing evidence base for psychotropic drugtreatment in pediatric patients, knowledge about the benefit-risk ratio inclinical practice remains limited. The ‘Therapeutic Drug Monitoring(TDM)-VIGIL’ study aimed to evaluate serious adverse drug reactions(ADRs) in children and adolescents treated with antidepressants and/orantipsychotics in approved (‘on-label’), and off-label use inclinical practice.  Methods Psychiatric pediatric patients aged 6-18 years treated withantidepressants and/or antipsychotics either on-label or off-label wereprospectively followed between October 2014 and December 2018 within amulticenter trial. Follow-up included standardized assessments of response,serious ADRs and therapeutic drug monitoring.  Results 710 youth (age=14.6±2.2 years,female=66.6%) were observed for 5.5 months on average;76.3% received antidepressants, 47.5% antipsychotics, and25.2% both. Altogether, 55.2% of the treatment episodes withantidepressants and 80.7% with antipsychotics were off-label. SeriousADRs occurred in 8.3% (95%CI=6.4–10.6%)of patients, mainly being psychiatric adverse reactions (77.4%),predominantly suicidal ideation and behavior. The risk of serious ADRs was notsignificantly different between patients using psychotropics off-label andon-label (antidepressants: 8.1% vs. 11.3%, p=0.16;antipsychotics: 8.7% vs 7.5%, p=0.67). Serious ADRsoccurred in 16.6% of patients who were suicidal at enrollment versus5.6% of patients who were not suicidal (relative risk 3.0,95%CI=1.9-4.9).  Conclusion Off-label use of antidepressants and antipsychotics in youthwas not a risk factor for the occurrence of serious ADRs in a closely monitoredclinical setting. Results from large naturalistic trials like ours cancontribute to bridging the gap between knowledge from randomized controlledtrials and real-world clinical settings.

Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice