Egberts, Karin M. and Gerlach, Manfred and Correll, Christoph U. and Plener, Paul L. and Malzahn, Uwe and Heuschmann, Peter and Unterecker, Stefan and Scherf-Clavel, Maike and Rock, Hans and Antony, Gisela and Briegel, Wolfgang and Fleischhaker, Christian and Hage, Alexander and Hellenschmidt, Tobias and Imgart, Harmut and Kaess, Michael and Karwautz, Andreas and Kolch, Michael and Reitzle, Karl and Renner, Tobias and Reuter-Dang, Su-Yin and Rexroth, Christian and Schulte-Korne, Gerd and Theisen, Frank M. and Walitza, Susanne and Wewetzer, Christoph and Fekete, Stefanie and Taurines, Regina and Romanos, Marcel (2022) Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice. PHARMACOPSYCHIATRY, 55 (05). pp. 255-265. ISSN 0176-3679, 1439-0795
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | UNTREATED PSYCHIATRIC-DISORDERS; SAFETY; PHARMACOVIGILANCE; MEDICATIONS; RELEVANCE; DURATION; GERMANY; TRIALS; antidepressants; antipsychotics; child; adverse drug reactions; safety |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Psychiatrie und Psychotherapie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 29 Jan 2024 09:09 |
| Last Modified: | 29 Jan 2024 12:52 |
| URI: | https://pred.uni-regensburg.de/id/eprint/58779 |
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