PMID- 32854103
OWN - NLM
STAT- MEDLINE
DCOM- 20211028
LR  - 20211028
IS  - 1423-0348 (Electronic)
IS  - 0033-3190 (Linking)
VI  - 90
IP  - 1
DP  - 2021
TI  - Post-Marketing Safety Concerns with Esketamine: A Disproportionality Analysis of 
      Spontaneous Reports Submitted to the FDA Adverse Event Reporting System.
PG  - 41-48
LID - 10.1159/000510703 [doi]
AB  - INTRODUCTION: Esketamine nasal spray received approval for treatment-resistant 
      depression in March 2019. OBJECTIVE: Using the FDA Adverse Event Reporting System 
      (FAERS) database (March 2019-March 2020), we analysed esketamine-related adverse 
      events (AEs) to detect and characterize relevant safety signals. METHODS: We used 
      the consolidated case/non-case approach to estimate the reporting odds ratio 
      (ROR) and information component (IC) with relevant confidence intervals (95% CI) 
      for esketamine-related AEs with >/=4 counts. Comparisons between serious and 
      non-serious AEs were performed using non-parametric tests. RESULTS: The FAERS 
      database contained 962 cases of esketamine-related AEs, with signals detected for 
      several AEs, such as dissociation (ROR = 1,612.64, 95% CI = 1,354.63, 1,919.79; 
      IC = 8.19, 95% CI = 7.96, 8.35), sedation (ROR = 238.46, 95% CI = 202.98, 280.15; 
      IC = 7, 95% CI = 6.75, 7.18), feeling drunk (ROR = 96.17, 95% CI = 61.42, 150.57; 
      IC = 4.84, 95% CI = 4.09, 5.36), suicidal ideation (ROR = 24.03, 95% CI = 18.72, 
      30.84; IC = 4.31, 95% CI = 3.9, 4.61), and completed suicide (ROR = 5.75, 95% CI 
      = 3.18, 10.41; IC = 2.25, 95% CI = 1.23, 2.94). Signals for suicidal and 
      self-injurious ideation, but not suicide attempt and completed suicide, remained 
      when comparing esketamine to venlafaxine. Females and patients receiving 
      antidepressant polypharmacy, co-medication with mood stabilizers, antipsychotics, 
      benzodiazepines, or somatic medications were more likely to suffer from serious 
      versus non-serious AEs (chi2 = 125.29, p < 0.001, chi2 = 9.08, p = 0.003, chi2 = 8.14, 
      p = 0.004, chi2 = 19.48, p < 0.001, chi2 = 25.62, p < 0.001, and chi2 = 16.79, p < 
      0.001, respectively). CONCLUSIONS: Esketamine may carry a clear potential for 
      serious AEs, which deserves urgent clarification by means of further prospective 
      studies.
CI  - (c) 2020 S. Karger AG, Basel.
FAU - Gastaldon, Chiara
AU  - Gastaldon C
AD  - WHO Collaborating Centre for Research and Training in Mental Health and Service 
      Evaluation, Department of Neuroscience, Biomedicine and Movement Sciences, 
      Section of Psychiatry, University of Verona, Verona, Italy, 
      chiara.gastaldon@gmail.com.
AD  - The Zucker Hillside Hospital, Department of Psychiatry, Northwell Health, Glen 
      Oaks, New York, USA, chiara.gastaldon@gmail.com.
FAU - Raschi, Emanuel
AU  - Raschi E
AD  - Department of Medical and Surgical Sciences, University of Bologna, Bologna, 
      Italy.
FAU - Kane, John M
AU  - Kane JM
AD  - The Zucker Hillside Hospital, Department of Psychiatry, Northwell Health, Glen 
      Oaks, New York, USA.
AD  - Department of Psychiatry and Molecular Medicine, Zucker School of Medicine at 
      Hofstra/Northwell, Hempstead, New York, USA.
AD  - The Feinstein Institute for Medical Research, Center for Psychiatric 
      Neuroscience, Manhasset, New York, USA.
FAU - Barbui, Corrado
AU  - Barbui C
AD  - WHO Collaborating Centre for Research and Training in Mental Health and Service 
      Evaluation, Department of Neuroscience, Biomedicine and Movement Sciences, 
      Section of Psychiatry, University of Verona, Verona, Italy.
FAU - Schoretsanitis, Georgios
AU  - Schoretsanitis G
AD  - The Zucker Hillside Hospital, Department of Psychiatry, Northwell Health, Glen 
      Oaks, New York, USA.
LA  - eng
PT  - Journal Article
DEP - 20200827
PL  - Switzerland
TA  - Psychother Psychosom
JT  - Psychotherapy and psychosomatics
JID - 0024046
RN  - 50LFG02TXD (Esketamine)
RN  - 690G0D6V8H (Ketamine)
SB  - IM
CIN - Psychother Psychosom. 2021;90(2):140-141. PMID: 33091915
CIN - Psychother Psychosom. 2021;90(2):138-139. PMID: 33108791
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Female
MH  - Humans
MH  - Ketamine
MH  - Marketing
MH  - *Pharmacovigilance
MH  - Prospective Studies
OTO - NOTNLM
OT  - Adverse drug reactions
OT  - Esketamine
OT  - Pharmacovigilance
OT  - Suicidality
OT  - Treatment-resistant depression
EDAT- 2020/08/28 06:00
MHDA- 2021/10/29 06:00
CRDT- 2020/08/28 06:00
PHST- 2020/06/27 00:00 [received]
PHST- 2020/07/30 00:00 [accepted]
PHST- 2020/08/28 06:00 [pubmed]
PHST- 2021/10/29 06:00 [medline]
PHST- 2020/08/28 06:00 [entrez]
AID - 000510703 [pii]
AID - 10.1159/000510703 [doi]
PST - ppublish
SO  - Psychother Psychosom. 2021;90(1):41-48. doi: 10.1159/000510703. Epub 2020 Aug 27.