Peer-reviewedCC BY-NC 4.0The International Journal of Risk & Safety in Medicine
Concerning the harm-benefit ratio of escitalopram for pediatric generalized anxiety disorder. A critical viewpoint on the evidence and approval process
7 affiliations
- 1Center for Inpatient Psychotherapy and Crisis Intervention, University Clinic for Psychiatry, Psychotherapy, and Psychosomatics, Paracelsus Medical University, Salzburg, Austria
- 2Research and Development Department, North East London NHS Foundation Trust, London, UK
- 3Institute of Pharmaceutical Science, King’s College London, London, UK
- 4University of Rennes, Rennes University Hospital, Inserm, Rennes Clinical Investigation Center (CIC1414), Clinical Pharmacology Department, Institute for Research in Health, Environment and Work (Irset)-UMR_S 1085, Rennes, France
- 5Institut Universitaire de France (IUF), Paris, France
- 6Ipswich, UK
- 7Division of Psychiatry, University College London, London, UK
Abstract
In this commentary we review the recent approval of escitalopram for generalized anxiety disorder (GAD) in children and adolescents. We critically discuss the FDA approval document and the approval trial. In the approval trial, efficacy was not clinically meaningful, statistical significance uncertain, and there were significantly more adverse events with escitalopram than with placebo. Relative to placebo, children and adolescents exposed to escitalopram were more likely to become suicidal than to experience a clinically relevant improvement in anxiety. Overall, the harm-benefit ratio seems problematic for escitalopram for pediatric GAD.
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BibTeX
@article{ploderl2026concerning,
title = {{Concerning the harm-benefit ratio of escitalopram for pediatric generalized anxiety disorder. A critical viewpoint on the evidence and approval process}},
author = {Martin Plöderl and Mark Horowitz and Florian Naudet and John Warren and Joanna Moncrieff},
journal = {The International Journal of Risk \& Safety in Medicine},
year = {2026},
month = may,
doi = {10.1177/09246479261456063},
url = {https://doi.org/10.1177/09246479261456063},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Concerning the harm-benefit ratio of escitalopram for pediatric generalized anxiety disorder. A critical viewpoint on the evidence and approval process
AU - Martin Plöderl
AU - Mark Horowitz
AU - Florian Naudet
AU - John Warren
AU - Joanna Moncrieff
PY - 2026
DA - 2026/05/28
JO - The International Journal of Risk & Safety in Medicine
DO - 10.1177/09246479261456063
UR - https://doi.org/10.1177/09246479261456063
AB - In this commentary we review the recent approval of escitalopram for generalized anxiety disorder (GAD) in children and adolescents. We critically discuss the FDA approval document and the approval trial. In the approval trial, efficacy was not clinically meaningful, statistical significance uncertain, and there were significantly more adverse events with escitalopram than with placebo. Relative to placebo, children and adolescents exposed to escitalopram were more likely to become suicidal than to experience a clinically relevant improvement in anxiety. Overall, the harm-benefit ratio seems problematic for escitalopram for pediatric GAD.
SN - 0924-6479
SN - 1878-6847
ER -