AUTHOR=Liu Ruixue , Liu Chunxiao , Feng Dianwei , Guo Tongxin , Wang Ying 

TITLE=Pharmacovigilance of esketamine nasal spray: an analysis of the FDA adverse event reporting system database

JOURNAL=Frontiers in Pharmacology

VOLUME=Volume 15 - 2024

YEAR=2024

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1414703

DOI=10.3389/fphar.2024.1414703

ISSN=1663-9812

ABSTRACT=Esketamine nasal spray (ESK-NS), as a new drug for treatment-resistant depression (TRD), we aimed to detect and characterize the adverse events (AEs) of ESK-NS using the Food and Drug Administration (FDA) adverse event reporting system (FAERS) database between 2019 Q1 to 2023 Q4.Reporting odds ratio (ROR), proportional reporting ratios (PRR), and Multi-item Gamma Poisson Shrinker (MGPS) were performed to detect risk signals from the FAERs data to identify potential ESK-NS-AEs associations. 14606 reports on AEs with ESK-NS as the primary suspected drug were analyzed. 518 preferred terms (PTs) signals and 25 system organ classes (SOCs), mainly concentrated in psychiatric disorders (33.20%), nervous system disorders (16.67%), general disorders and administration site conditions (14.21%), and others, were obtained. Notably, dissociation (n=1093, ROR 2257.80, PRR 899.64, EBGM 876.86) exhibited highest occurrence rates and signal intensity. Moreover, uncommon but significantly strong AEs signals, such as hand-eye coordination impaired, feeling guilty, and feelings of worthlessness were observed. Additionally, dissociative disorder (n = 57, ROR 510.92, PRR 506.70, EBGM 386.60) and sedation (n = 688, ROR 172.68, PRR 155.53, EBGM 142.05) both presented strong AEs signals, and the former is not recorded in the Summary of Product Characteristics (SmPC). In clinical applications, close attention should be paid to the Psychiatric disorders and Nervous system disorders, especially dissociation. Meanwhile, clinical professionals should be alert for the occurrence of AEs signals not mentioned in the SmPC, take preventive measures so as to ensure the safety of clinical use.