Serious adverse drug reactions in children and adolescents treated on- and off-label with antidepressants and antipsychotics in clinical practice

Media type: E-Article

Title: Serious adverse drug reactions in children and adolescents treated on- and off-label with antidepressants and antipsychotics in clinical practice

Contributor: Egberts, Karin M. [Author]; Gerlach, Manfred [Author]; Correll, Christoph U. [Author]; Plener, Paul L. [Author]; Malzahn, Uwe [Author]; Heuschmann, Peter [Author]; Unterecker, Stefan [Author]; Scherf-Clavel, Maike [Author]; Rock, Hans [Author]; Antony, Gisela [Author]; Briegel, Wolfgang [Author]; Fleischhaker, Christian [Author]; Häge, Alexander [Author]; Hellenschmidt, Tobias [Author]; Imgart, Harmut [Author]; Kaess, Michael [Author]; Karwautz, Andreas [Author]; Kölch, Michael [Author]; Reitzle, Karl [Author]; Renner, Tobias [Author]; Reuter-Dang, Su-Yin [Author]; Rexroth, Christian A. [Author]; Schulte-Körne, Gerd [Author]; Theisen, Frank M. [Author]; Walitza, Susanne [Author]; Wewetzer, Christoph [Author]; Fekete, Stefanie [Author]; Taurines, Regina [Author]; Romanos, Marcel [Author]

Published: 1 September 2022

Language: English

DOI: 10.1055/a-1716-1856

Identifier:

Origination:

Footnote:

Description: 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.

Access State: Open Access

Search in field:

Recently searched for: