The evidence-based choice for antipsychotics in children and adolescents should be guaranteed

  • Daria Putignano
  • Antonio Clavenna
  • Laura Reale
  • Maurizio BonatiEmail author



Drug use in the pediatric population still often features off-label prescriptions, particularly for psychotropic drugs. We reviewed the registration status, scientific evidence, and recommendations from the guidelines for antipsychotics used for psychiatric disorders in children.


Antipsychotic drugs marketed in Italy, the United Kingdom (UK) and United States (US) were identified with the ATC Classification System. The licensing status and Summary of Product Characteristics (SPC) were taken from the national formularies. We analyzed reviews and guidelines on antipsychotics use in children and adolescents in the MEDLINE, EMBASE, and PsycINFO databases.


Out of 67 drugs, 19 were marketed with a pediatric license in at least one country: three in all the selected countries, and only paliperidone with the same indications. Haloperidol was the only antipsychotic authorized for autism in Italy and the UK, and as well as risperidone and aripiprazole in the US. Aripiprazole and paliperidone were licensed in all three countries for schizophrenia. Aripiprazole was licensed for bipolar disorders in all three countries. Haloperidol was licensed for Tourette syndrome in Italy and the UK, and pimozide and aripiprazole in the US.

We retrieved 21 pertinent reviews and 13 guidelines for the management of neuropsychiatric disorders in pediatrics. There was a complete overlap between the authorized therapeutic indications and the available scientific evidence for autism in the US, for conduct disorders and bipolar disorders in the UK, and for Tourette syndrome and tics in the UK and Italy.


These results highlight the different regulatory processes that deny to many children and adolescents the most appropriate and rational antipsychotic therapy.


Adolescent Antipsychotic agents Child Mental disorders Off-label drug use 



The authors would like to acknowledge Judith Baggott for language editing.

Author contributions

All the authors contributed equally to the design of the study. DP wrote the first draft of the manuscript. AC contributed in writing the manuscript. LR and MB supervised the study. All authors contributed to and have approved the final manuscript.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Supplementary material

228_2019_2641_MOESM1_ESM.docx (17 kb)
ESM 1 (DOCX 16 kb)


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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Laboratory for Mother and Child Health, Department of Public Health - Istituto di Ricerche Farmacologiche Mario Negri IRCSSMilanItaly

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