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Off-Label Prescribing of Antipsychotics for Youths: Who Should Be Treated?

Off-Label Prescribing of Antipsychotics for Youths: Who Should Be Treated?

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FDA-approved antipsychotic medications and corresponding conditions for youthTABLE. FDA-approved antipsychotic medications and corresponding condit...

Psychiatric Controversies

In recent years, treatment options for several child and adolescent psychiatric problems have increasingly relied on antipsychotic medications. The rise in prescriptions for youths has generated public and professional concern over the appropriate role of pharmacology in child psychiatry. Criticism is seen in mainstream media and in discussions of restricting off-label use of psychiatric medications. These concerns center on adverse effects of medications, high rates of prescribing, and off-label prescribing. Implicit is an assumption that antipsychotics have no treatment role outside of their FDA-approved indications (Table).

However, findings in neurobiology and clinical trials support off-label use of antipsychotics for treatment of impulsivity and aggression in youths. To correctly utilize this knowledge, physicians need a strong understanding of the evidence-based literature that supports off-label antipsychotic prescribing. In addition, physicians must understand the issues surrounding unsupported off-label prescribing. This knowledge will guide and inform diagnostic evaluation and decision-making toward appropriate prescribing practices.

This article focuses on appropriate versus inappropriate use of antipsychotics, the importance of careful assessment, and the consequences of not treating.

Supported off-label prescribing

The concern that antipsychotic prescribing in youth is inappropriate outside of FDA-indicated conditions is understandable. The nomenclature “antipsychotic” suggests it is for patients who are psychotic, and the lack of an FDA indication for a condition is often conflated with a lack of evidence. In fact, off-label prescribing is a central and common source of treatment throughout medicine, particularly psychiatry.

Many of the medications that are prescribed off-label have evidence-based and clinical literature to support their use. This distinction between supported and unsupported off-label prescribing practices is important, as it balances efficacy with risk of use. Supported off-label prescribing is the use of medications for a non–FDA-approved indication when there is moderate to high certainty of a net benefit. That certainty is informed by known scientific evidence that grounds the practice. Unsupported off-label prescribing is use that is suppositional or even investigative. In unsupported prescribing, there is a low or very low level of certainty that the medicine will have a net benefit.

Antipsychotics have historical FDA data, neuroscience, and clinical trials that justify them as supported off-label prescribing for severe behavior problems, such as aggression. While atypical antipsychotics lack FDA indications for disruptive behavior disorders, typical antipsychotics such as haloperidol and chlorpromazine are approved for agitation and severe behavior problems in youth.


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