Dataset Information

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

ABSTRACT:

Introduction

Despite the growing evidence base for psychotropic drug treatment in pediatric patients, knowledge about the benefit-risk ratio in clinical 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/or antipsychotics in approved ('on-label'), and off-label use in clinical practice.

Methods

Psychiatric pediatric patients aged 6-18 years treated with antidepressants and/or antipsychotics either on-label or off-label were prospectively followed between October 2014 and December 2018 within a multicenter 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, and 25.2% both. Altogether, 55.2% of the treatment episodes with antidepressants and 80.7% with antipsychotics were off-label. Serious ADRs 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 not significantly different between patients using psychotropics off-label and on-label (antidepressants: 8.1% vs. 11.3%, p=0.16; antipsychotics: 8.7% vs 7.5%, p=0.67). Serious ADRs occurred in 16.6% of patients who were suicidal at enrollment versus 5.6% 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 youth was not a risk factor for the occurrence of serious ADRs in a closely monitored clinical setting. Results from large naturalistic trials like ours can contribute to bridging the gap between knowledge from randomized controlled trials and real-world clinical settings.

SUBMITTER: Egberts KM

PROVIDER: S-EPMC9458344 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Publications

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

Egberts Karin M KM Gerlach Manfred M Correll Christoph U CU Plener Paul L PL Malzahn Uwe U Heuschmann Peter P Unterecker Stefan S Scherf-Clavel Maike M Rock Hans H Antony Gisela G Briegel Wolfgang W Fleischhaker Christian C Häge Alexander A Hellenschmidt Tobias T Imgart Harmut H Kaess Michael M Karwautz Andreas A Kölch Michael M Reitzle Karl K Renner Tobias T Reuter-Dang Su-Yin SY Rexroth Christian C Schulte-Körne Gerd G Theisen Frank M FM Walitza Susanne S Wewetzer Christoph C Fekete Stefanie S Taurines Regina R Romanos Marcel M

Pharmacopsychiatry 20220207 5

<h4>Introduction</h4>Despite the growing evidence base for psychotropic drug treatment in pediatric patients, knowledge about the benefit-risk ratio in clinical 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/or antipsychotics in approved ('on-label'), and off-label use in clinical practice.<h4>Methods</h4>Psychiatric pediatric patients aged 6-18 year ...[more]

PMID: 35130562

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Dataset Information

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

Introduction

Methods

Results

Conclusion

Publications

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

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