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.

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.

Who takes the psychiatric drugs: the children, or the young adults?

An analysis run directly on the national e-prescribing database (EOPYY/IDIKA), ages 0–29, 2020–2024, found that children (0–17) are markedly less likely to be prescribed than young adults (18–29) in every drug category — odds ratio 0.044 for SSRIs, 0.045 for second-generation antipsychotics. Prescribing concentrates mainly in young adults, not children. The number of child patients peaked in 2022 (9,444) and eased slightly by 2024 (9,061).

A separate study using 2017 Greek IDIKA data found that 14% of children who received a psychiatric drug received one with no pediatric information on the label, and 7.6% outside the approved age range — with quetiapine the most common off-label substance.

ADHD stimulants and the heart: one clear finding, three weaker ones

Four recent studies looked at different angles of the same question. They do not converge on the same finding — their weight differs substantially: one clear but narrow hypertension signal, one meta-analysis with follow-up far too short for a long-term conclusion, one borderline stroke finding, and one preliminary finding that remains unpublished.

Care before starting stimulants has already included, since 2008 (AHA and AAP guidance), taking a personal and family cardiac history — fainting episodes, palpitations, known heart conditions, sudden cardiac death in a relative; routine ECGs for everyone are not recommended. The studies below add detail to an already-monitored risk category — they do not reveal one nobody was watching.

Swedish study (JAMA Psychiatry 2024, 278,027 individuals, follow-up up to 14 years): each additional year of ADHD medication use is associated with a 4% increased risk of a cardiovascular event per year (AOR 1.04) — but the risk is driven almost entirely by hypertension (AOR up to 1.80 beyond 5 years); stroke, heart failure, ischemic heart disease and arrhythmia showed no statistically significant increase. It is not stimulant-specific — it pools non-stimulants (atomoxetine, guanfacine) together with stimulants, and the risk plateaus after 5 years rather than continuing to climb. The same research group had published a largely reassuring meta-analysis of the prior literature in 2022; this is their own newer, larger, longer-follow-up dataset finding a more specific signal — not two independent groups in disagreement.

NIHR-funded network meta-analysis (Lancet Psychiatry 2025, 102 randomised trials, 22,702 participants): small short-term effects on blood pressure and heart rate — but median follow-up was just 7 weeks, and the authors themselves state plainly that this is not long enough to draw a long-term conclusion.

Danish registry study (JACC 2024): current versus former use compared, with risk projected to a standardised 10-year horizon — actual median follow-up was 6.7 years. Stroke risk ratio 1.2 (95% CI 1.0–1.5 — the lower bound touches the null result, borderline significance), heart failure risk ratio 1.7 (CI 1.3–2.2), no significant increase in acute coronary syndrome.

What holds up steadily across these four studies is a specific hypertension finding, not a generalised cardiovascular risk; the single most dramatic absolute figure (cardiomyopathy) remains unpublished. Do not stop an ADHD medication abruptly without your doctor's guidance — abrupt discontinuation carries its own risks: returning symptoms, mood disturbance, and the consequences of unmanaged ADHD for driving, school, and work.

One junior doctor without supervision, 227 children at risk, 46 with documented harm — and 140 "lost" to follow-up

Ireland's Health Service Executive (HSE) commissioned an independent look-back review of the files of a child and adolescent mental health service (CAMHS) in South Kerry, after concerns were raised by a fellow doctor in the same service and, in September 2020, by the locum consultant child psychiatrist. Dr Sean Maskey, a child psychiatrist, led the review of 1,332 files from July 2016 to April 2021. The report (final, 14 January 2022, anonymised as "Area A") finds: 227 children under the care of one junior hospital doctor — a Senior House Officer, "one level up from intern", in a non-training post — were "exposed … to the risk of significant harm" by diagnosis or treatment — sedation, emotional and cognitive blunting, growth disturbance and serious weight changes, metabolic and endocrine disturbance, and psychological distress; 13 more under other doctors of the service; and "clear evidence of significant harm caused to 46 children": "galactorrhoea (the production of breast milk), considerable weight gain, sedation during the day, and elevated blood pressure". "No extreme or catastrophic harm," the same report writes, and we pass it on.

How it happened, according to the report. Its first treatment finding: "frequent use of neuroleptic medication to control behaviour and/or subjective emotional distress in children when it is not indicated clinically", the wrong class of medication for the symptoms, and unnecessary combinations — 31 children were on four categories of medication at once, two on five. ADHD diagnoses "frequently made without adequate evaluation" and without information from the school. In Ireland, risperidone is licensed for children only in autism and conduct and other disruptive behaviour disorders, with maximum doses, and aripiprazole is licensed; the other antipsychotics are not licensed for children at all. And "inconsistent and inadequate monitoring of adverse effects": children started on antipsychotics "did not routinely have a baseline blood test", results were "not on file in the majority of cases", and measurements of weight, height, pulse and blood pressure were "erratic and not plotted on developmental charts". The doctor was not available for interview. The team's consultant post had been vacant since July 2016, the expected weekly supervision "became very infrequent" from January 2017, and "there was no contractual requirement, or support and monitoring through supervision, to develop skills in the sub-specialty of child and adolescent psychiatry". The problem, Maskey writes, was not one doctor: not asking teachers for feedback "was the practice of the doctors who were prescribing for ADHD in general", and the missing pulse and blood-pressure check seven days after starting a stimulant "was not specific to NCHD1" — it does not appear to have been the clinic's practice.

And then, at national scale. The Inspector of Mental Health Services, Dr Susan Finnerty, reviewed every CAMHS team in the country in 2022–2023. Report, July 2023: "On one team, 140 children who had open cases had been lost to follow-up" — among them children on medication, some reaching their 18th birthday with no transition plan or advice about their medication; the HSE assured the Inspector that all children lost to follow-up had been identified, their care reviewed, and that "no harm was found to have occurred". "Another team … did not follow up their patients for up to two years despite these children being on continuing medication." "The vast majority of teams" were "significantly below the recommended staffing levels, some below 50%". And the sentence that judges the visit: "I cannot currently provide an assurance to all parents or guardians in all parts of Ireland that their children have access to a safe, effective, and evidence-based mental health service." First recommendation: the immediate, independent regulation of CAMHS by the Mental Health Commission.

What this is and what it is not. It is not a study of whether the drugs harm children; it is a state inquiry into what happens when they are given without indication, without supervision and without the monitoring that the guidelines themselves require. The 46 harms are the known adverse effects of antipsychotics and stimulants — the raised blood pressure belongs to the latter — and the report itself warns that, precisely because monitoring was inadequate, attributing harm to treatment "is more problematic", and that the figure of 46 "will change". What the FDA sees in its reporting database, above, here has files. And what applies across this page applies here: do not stop a child's medication abruptly without the treating doctor — in Kerry itself, the medication review was done by a specialist, gradually.

The antipsychotic injection given to a child as restraint — 91,898 admissions at 43 US hospitals, and which children receive it — is documented on the sister site: Part B of psychpractices.org.