Children, fifteen years on

Eight in ten antipsychotic prescriptions to children are outside approved use

A prospective multicentre study across 18 centres in Germany, Austria and Switzerland followed 700 children and adolescents (mean age 14.6, 67% girls) receiving antidepressants or antipsychotics.

"Off-label" means either that the drug is not approved for the child's age, or not approved for the condition, or both — which was the case for 37.4% of antipsychotic prescriptions.

Off-label prescribing is not illegal, and it is often the only option available: trials in minors are few, expensive and ethically difficult. The problem is different — when four in five children receive a drug outside the setting in which its safety was tested, the side-effect evidence base simply does not exist. The researchers themselves call for stronger pharmacovigilance.

[20] Taurines R, Gerlach M, Correll CU et al. Child Adolesc Psychiatry Ment Health, 13.10.2025 · doi:10.1186/s13034-025-00957-7

What the FDA's own adverse-event database shows

FAERS is the US regulator's public adverse-event reporting database — a government system, freely accessible. A 2026 analysis identified 18,779 reports for ages 5–19 years over the period 1997–2024 in which a suicide-related event was recorded; 22.3% of these were coded as completed suicide, with the proportion rising with age.

A parallel analysis of seven antipsychotics in reports concerning children under 12 found disproportionate reporting of neuroleptic malignant syndrome for aripiprazole, haloperidol, quetiapine and risperidone, and of QT prolongation for ziprasidone and risperidone.

The FDA itself says so, verbatim: “The existence of an adverse event report for a drug in FAERS does not mean that the drug caused the adverse event” and “for any given report, there is no certainty that the suspected drug caused the reaction”. The system is voluntary, is subject to under-reporting and to selective over-reporting, and does not permit the calculation of incidence.

I cite it as a signal, with that limitation stated. Presented as proof of deaths, it would be demolished in a minute and would take the rest of the evidence down with it. As a signal from a government system, it cannot be rebutted — and the fact that no one has adequately investigated 18,779 reports is itself a finding.

[43] Legal Medicine (Tokyo) 2026;81:102800 · [44] Kimura et al. Int J Med Sci 2015;12(2):135–140 · [45] Wu L et al. FAERS ADHD, 2004–2023 · [46] FDA, FAERS Public Dashboard — statements of limitations