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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 children a...

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Autores principales: 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, Schulte-Körne, Gerd, Theisen, Frank M., Walitza, Susanne, Wewetzer, Christoph, Fekete, Stefanie, Taurines, Regina, Romanos, Marcel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Georg Thieme Verlag KG 2022
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9458344/
https://www.ncbi.nlm.nih.gov/pubmed/35130562
http://dx.doi.org/10.1055/a-1716-1856
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author 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
Schulte-Körne, Gerd
Theisen, Frank M.
Walitza, Susanne
Wewetzer, Christoph
Fekete, Stefanie
Taurines, Regina
Romanos, Marcel
author_facet 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
Schulte-Körne, Gerd
Theisen, Frank M.
Walitza, Susanne
Wewetzer, Christoph
Fekete, Stefanie
Taurines, Regina
Romanos, Marcel
author_sort Egberts, Karin M.
collection PubMed
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.
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spelling pubmed-94583442022-09-09 Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice 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 Schulte-Körne, Gerd Theisen, Frank M. Walitza, Susanne Wewetzer, Christoph Fekete, Stefanie Taurines, Regina Romanos, Marcel Pharmacopsychiatry 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. Georg Thieme Verlag KG 2022-02-07 /pmc/articles/PMC9458344/ /pubmed/35130562 http://dx.doi.org/10.1055/a-1716-1856 Text en The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/). https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited.
spellingShingle 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
Schulte-Körne, Gerd
Theisen, Frank M.
Walitza, Susanne
Wewetzer, Christoph
Fekete, Stefanie
Taurines, Regina
Romanos, Marcel
Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice
title Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice
title_full Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice
title_fullStr Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice
title_full_unstemmed Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice
title_short Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice
title_sort serious adverse drug reactions in children and adolescents treated on- and off-label with antidepressants and antipsychotics in clinical practice
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9458344/
https://www.ncbi.nlm.nih.gov/pubmed/35130562
http://dx.doi.org/10.1055/a-1716-1856
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