An International Comparison of the Information in the Regulatory-Approved Drug Labeling and Prescribing Guidelines for Pediatric Depression

Laila Tanana, Asam Latif, Prasad S Nishtala, David Taylor, Timothy F Chen

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Objectives: To determine the differences in information between prescribing guidelines and drug labeling, as well as to compare the approval of psychotropic medicines for major depression in pediatric patients ("pediatric depression") across countries. Methods: The recommendations of The Maudsley Prescribing Guidelines in Psychiatry (MPGP) for the treatment of pediatric depression (<18 years) were compared against the regulatory-approved drug-labeling documents from the United Kingdom, Australia, New Zealand, Canada, and the United States. The use of medicines outside of their regulatory approval is defined as off-label use, so differences between the drug labeling and MPGP were characterized according to unapproved age, indication, dosage, or route of administration. Information in the drug labeling was also compared across countries. Results: MPGP provides recommendations for 6 medicines for the treatment of pediatric depression, for which, 30 drug labeling were retrieved. Three of 30 drug labeling were consistent with MPGP recommendations (fluoxetine in the United Kingdom, fluoxetine and escitalopram in the United States). Differences in information between MPGP and the drug labeling were identified in 26 of 30 drug labeling analyzed, most often due to age (24/26) followed by indication (2/26). No differences pertaining to dosage or route of administration information were identified. The number of approved psychotropic medicines varied across the studied countries and we found cross-country discrepancies in information in the drug labeling. Conclusion: Significant differences in information exists between MPGP and the drug labeling for psychotropic medicines for pediatric depression, due to unapproved ages or indications. Additionally, approval information in the drug labeling are not consistent across countries. Further research into reasons for variability and impact on practice may be warranted.

Original languageEnglish
Pages (from-to)294-309
Number of pages16
JournalJournal of child and adolescent psychopharmacology
Issue number4
Early online date18 Feb 2021
Publication statusPublished - 31 May 2021

Bibliographical note

Publisher Copyright:
© Copyright 2021, Mary Ann Liebert, Inc., publishers 2021.


  • SmPC
  • antidepressants
  • depression
  • drug labeling
  • off-label use
  • pediatric

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Psychiatry and Mental health
  • Pharmacology (medical)


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