Publikation: Zeitschriftenartikel

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

Grunddaten
Abstract
Autoren
Einrichtung

Grunddaten

Titel	Serious adverse drug reactions in children and adolescents treated on- and off-label with antidepressants and antipsychotics in clinical practice
Erscheinungsjahr	2022
Seiten (von – bis)	255 – 265
Band	55
Heft-Nr.	5
Jahr	2022
Publikationsform	Elektronische Ressource
Publikationsart	Zeitschriftenartikel
Sprache	Englisch
DOI	10.1055/a-1716-1856
Letzte Änderung	15.12.2022 06:01:55
Bearbeitungsstatus	durch UB Rostock abschließend validiert
Dauerhafte URL	http://purl.uni-rostock.de/fodb/pub/68856
Links zu Katalogen

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.

Autoren

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

Einrichtung

UMR/Klinik und Poliklinik für Psychiatrie, Neurologie, Psychosomatik und Psychotherapie im Kindes- und Jugendalter (KJPP)