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

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...

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Hauptverfasser: Egberts, Karin M. (VerfasserIn) , Gerlach, Manfred (VerfasserIn) , Correll, Christoph U. (VerfasserIn) , Plener, Paul L. (VerfasserIn) , Malzahn, Uwe (VerfasserIn) , Heuschmann, Peter (VerfasserIn) , Unterecker, Stefan (VerfasserIn) , Scherf-Clavel, Maike (VerfasserIn) , Rock, Hans (VerfasserIn) , Antony, Gisela (VerfasserIn) , Briegel, Wolfgang (VerfasserIn) , Fleischhaker, Christian (VerfasserIn) , Häge, Alexander (VerfasserIn) , Hellenschmidt, Tobias (VerfasserIn) , Imgart, Harmut (VerfasserIn) , Kaess, Michael (VerfasserIn) , Karwautz, Andreas (VerfasserIn) , Kölch, Michael (VerfasserIn) , Reitzle, Karl (VerfasserIn) , Renner, Tobias (VerfasserIn) , Reuter-Dang, Su-Yin (VerfasserIn) , Rexroth, Christian A. (VerfasserIn) , Schulte-Körne, Gerd (VerfasserIn) , Theisen, Frank M. (VerfasserIn) , Walitza, Susanne (VerfasserIn) , Wewetzer, Christoph (VerfasserIn) , Fekete, Stefanie (VerfasserIn) , Taurines, Regina (VerfasserIn) , Romanos, Marcel (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 1 September 2022
In: Pharmacopsychiatry
Year: 2022, Jahrgang: 55, Heft: 5, Pages: 255-265
ISSN:1439-0795
DOI:10.1055/a-1716-1856
Online-Zugang:Resolving-System, kostenfrei: https://doi.org/10.1055/a-1716-1856
Verlag, kostenfrei, Volltext: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9458344/
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Verfasserangaben:authors: Karin M. Egberts, Manfred Gerlach, Christoph U. Correll, Paul L. Plener, Uwe Malzahn, Peter Heuschmann, Stefan Unterecker, Maike Scherf-Clavel, Hans Rock, Gisela Antony, Wolfgang Briegel, Christian Fleischhaker, Alexander Häge, Tobias Hellenschmidt, Harmut Imgart, Michael Kaess, Andreas Karwautz, Michael Kölch, Karl Reitzle, Tobias Renner, Su-Yin Reuter-Dang, Christian Rexroth, Gerd Schulte-Körne, Frank M. Theisen, Susanne Walitza, Christoph Wewetzer, Stefanie Fekete, Regina Taurines, Marcel Romanos
Beschreibung
Zusammenfassung: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.
Beschreibung:Online Resource
ISSN:1439-0795
DOI:10.1055/a-1716-1856

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