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

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

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

Erschienen: 1 September 2022

Sprache: Englisch

DOI: 10.1055/a-1716-1856

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Beschreibung: 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.

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