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Safety of esketamine nasal spray: Analysis of post-marketing reports submitted to the FDA adverse event reporting system in the first year on the market

Published online by Cambridge University Press:  13 August 2021

C. Gastaldon ,
E. Raschi ,
J. Kane  and
C. Barbui
C. Gastaldon*
Affiliation:
University Of Verona, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Verona, Italy Neuroscience, Psychological And Psychiatric Science, Science Of Bio Movement, University of Verona, Verona, Italy
E. Raschi
Affiliation:
Department Of Medical And Surgical Sciences, University of Bologna, Bologna, Italy
J. Kane
Affiliation:
Department Of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY, United States of America
C. Barbui
Affiliation:
University Of Verona, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Verona, Italy
*
*Corresponding author.

Abstract

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Introduction

The approval of the esketamine nasal spray for treatment-resistant depression in March 2019 by the Food and Drug Administration (FDA), and few months later by the European Medicine Agency, triggered a vivid debate and many concerns, mainly because of the lack of convincing evidence on its efficacy and safety, based on the development programs, approval trials and few post-marketing trials.

Objectives

We aimed to detect and characterize safety signals for esketamine, by analyzing relevant adverse events (AEs) reports in the FDA Adverse Event Reporting System (FAERS) database (March 2019-March 2020).

Methods

We performed disproportionality analysis through the case/non-case approach: reporting odds ratios (ROR) and information components (IC) with 95% confidence intervals (95%CI) were estimated for esketamine-related AEs with at least four counts. We compared serious and non-serious AEs using non-parametrical tests.

Results

The FAERS database registered 962 reports of esketamine-related AEs in one year. Signals (i.e., statistically significant disproportionality) were detected for several AEs, such as dissociation, sedation, feeling drunk, suicidal ideation and completed suicide. Signals for suicidal ideation, but not suicide attempt and completed suicide, remained significant when comparing esketamine to venlafaxine. The comparison of patients with serious vs. non-serious esketamine AEs revealed that females, patients receiving antidepressant polypharmacy, co-medication with antipsychotics, mood stabilizers, benzodiazepines or somatic medications were more likely to suffer from serious AEs.

Conclusions

This real-world pharmacovigilance analysis detected signals of serious unexpected esketamine-related AEs, thus reinforcing current worries regarding esketamine safety/acceptability. Further real-world studies are urgently needed to unravel the safety profile of esketamine.

Disclosure

No significant relationships.

Keywords

treatment-resistant depressionpharmacovigilanceesketamineSuicidal risk
Type
Abstract
Information
European Psychiatry , Volume 64 , Special Issue S1: Abstracts of the 29th European Congress of Psychiatry , April 2021 , pp. S150 - S151
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© The Author(s), 2021. Published by Cambridge University Press on behalf of the European Psychiatric Association
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