Cardiac and metabolic safety profile of antipsychotics in youths: A WHO safety database analysis

Merino, Diane; Gérard, Alexandre O.; Destere, Alexandre; Saidessalam, Haitam; Askenazy, Florence; Montastruc, François; Drici, Milou-Daniel; Thümmler, Susanne

doi:10.1016/j.psychres.2024.115786

Cited by 1 publication

(1 citation statement)

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“…Moreover, restrictive marketing authorizations may also be responsible for the higher off-label rate in children and adolescents [ 15 , 16 ]. This has caused widespread concern about the efficacy and safety of antipsychotics in pediatric patients because psychiatric adverse events are more likely to be observed in pediatric patients [ 17 , 18 ].…”

Section: Introductionmentioning

confidence: 99%

Trends and off-label utilization of antipsychotics in children and adolescents from 2016 to 2021 in China: a real-world study

Zhaojian,

Meizhu,

Jun

et al. 2024

Child Adolesc Psychiatry Ment Health

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Background Global antipsychotic usage, including off-label prescriptions, has increased in recent decades. However, trends in China, particularly for children and adolescents, remain unclear. This study explored these trends from 2016 to 2021 and identified factors associated with off-label prescriptions. Methods In this retrospective study, we analyzed on-label and off-label prescriptions based on drug information approved by the China National Medical Products Administration. To identify factors associated with off-label prescriptions, we conducted multivariate logistic regression analysis. Results Our study included 48,258 antipsychotic prescriptions, 52.4% (25,295) of which were prescriptions for males. Of these, 61.7% (29,813) were off-label. Over time, the number of antipsychotics and the percentage of off-label prescriptions for children and adolescents overall increased from 2016 to 2021. The use of atypical antipsychotics increased, whereas that of typical antipsychotics decreased. For off-label usage, all of the factors in our study were associated with off-label usage, including age, sex, year, region, department, reimbursement, antipsychotic type, drug expense, number of polypharmacy and diagnoses. Additionally, tiapride (15.8%) and aripiprazole (18.6%) were the most common typical and atypical antipsychotics, respectively. For pediatric diseases, common diagnoses included mood or affective disorders (31.7%) and behavioral and emotional disorders, with onset usually occurring in childhood and adolescence (29.1%). Furthermore, a depressive state was the most common diagnosis for which antipsychotic polypharmacy was used for treatment. Conclusion In this retrospective study, off-label antipsychotic prescriptions were common, with trends generally increasing among children and adolescents from 2016 to 2021. However, there is a lack of evidence supporting off-label usage, thus emphasizing the need for studies on the efficacy and safety of these treatments.

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