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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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
1 September 2022
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| In: |
Pharmacopsychiatry
Year: 2022, Volume: 55, Issue: 5, Pages: 255-265 |
| ISSN: | 1439-0795 |
| DOI: | 10.1055/a-1716-1856 |
| Online Access: | 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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| Author Notes: | 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 |
| Summary: | 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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| Physical Description: | Online Resource |
| ISSN: | 1439-0795 |
| DOI: | 10.1055/a-1716-1856 |