Extent and Risks of Antipsychotic Off-Label Use in Children and Adolescents in Germany Between 2004 and 2011

Schröder, Carsten; Dörks, Michael; Kollhorst, Bianca; Blenk, Tilo; Dittmann, Ralf W.; Garbe, Edeltraut; Riedel, Oliver

doi:10.1089/cap.2016.0202

Cited by 9 publications

(15 citation statements)

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“…The proportion of off-label prescriptions in our population was slightly higher than in previous epidemiological studies from Germany in antidepressants (40.9–49.1%) 13 15 and antipsychotics (52.3–71.1%) 16 . This could be explained by the fact that the majority of our patients were inpatients in specialized centers and that specialist treatment by hospital doctors increases the likelihood of receiving an off-label prescription 13 .…”

Section: Discussioncontrasting

confidence: 80%

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Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice

et al. 2022

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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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Section: Discussioncontrasting

confidence: 80%

“…In addition, off-label prescribing is very common in child and adolescent psychiatry, with frequencies of around 50% for antidepressants 13 14 15 and up to 95% for antipsychotics 14 16 in European studies. This is concerning, as off-label prescribing exposes patients to unknown risks of ineffective or even harmful treatment 3 17 18 .…”

Section: Introductionmentioning

confidence: 99%

Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice

et al. 2022

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“…Многие антипсихотики FDA [8] не рекомендует к применению до 18 лет, и это актуально для большинства стран мира [13]. Тем не менее их назначение «вне показаний» у детей и подростков достаточно распространено [13,15]. В России, согласно Государственному реестру лекарственных средств [16], до 18 лет могут использоваться лишь некоторые АВГ и почти все АПГ, хотя есть ограничения для детей младше 15 лет (табл.…”

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“…В работе С. Schröder и соавт. [15] не выявлено различий безопасности антипсихотиков в зависимости от их использования согласно инструкции или «вне показаний». Учитывая небольшой выбор антипсихотиков, риск развития резистентности, требуется больше информации о возможных рисках применения антипсихотиков «вне показаний» по возрастному признаку.…”

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Off-label antipsychotics prescription to adolescents with acute psychotic episodes does not cause adverse drug reactions

Ivashchenko

Buromskaya

Malakhova

et al. 2021

RJTAO

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Antipsychotics are often used to treat children and adolescents. Because of their age, there are a lot of off-label prescribed antipsychotics in that population. However, the off-label use of medications is considered to be potentially unsafe.Objective: to evaluate whether the off-label prescription of antipsychotics outside of the approved age group increased the risk of adverse drug reactions in adolescents experiencing an acute psychotic episode.Patients and methods. We analyzed 450 charts of adolescents hospitalized due to an acute psychotic episode (only completed cases). In addition, we evaluated adverse drug reactions adjusted by off-label antipsychotics prescription outside the approved age group using the Global Trigger Tool (GTT). We also registered prescriptions with duplicates drug classes and potentially dangerous drug interactions.Results and discussion. Off-label antipsychotics prescription outside the approved age group was less frequently associated with adverse drug reactions (3.2% vs. 10.5%; p=0.013). The logistic regression analysis did not show any significant associations between the off-label antipsychotic use and increased risk of adverse drug reactions (Odds ratio=0.994 (95% confidence interval 0.572-1.726), p=0.982). Although, patients with off-label use of antipsychotics were more likely to have potentially dangerous drug interactions (35.2% vs. 16.15%; p=0.0001) and prescriptions with duplicates drug classes (39.6% vs. 15.43%; p=0.0001).Conclusion. Off-label antipsychotic prescription outside the approved age group in adolescents with acute psychotic episode does not increase the risk of adverse drug reactions. However, an increase in potentially dangerous drug interactions and prescriptions with duplicates drug classes frequency could be considered red flags. Therefore, we have concluded that the concerns about off-label antipsychotics prescription outside of approved age groups in adolescents with acute psychotic episodes were overrated.

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Prescription prevalence of psychotropic drugs in children and adolescents: an analysis of international data

Piovani

Clavenna

Bonati

2019

Eur J Clin Pharmacol

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Extent and Risks of Antipsychotic Off-Label Use in Children and Adolescents in Germany Between 2004 and 2011

Cited by 9 publications

References 30 publications

Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice

Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice

Off-label antipsychotics prescription to adolescents with acute psychotic episodes does not cause adverse drug reactions

Prescription prevalence of psychotropic drugs in children and adolescents: an analysis of international data

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