(P-264) Evaluation of Esketamine Adverse Event from the FAERS Database and Published Case Reports

Background: Esketamine (Spravatotm) is a newly approved therapy for treatment-resistant depression (TRD) and major depressive disorder (MDD) with acute suicidal ideation/behavior in adults. Esketamine is available through a Risk Evaluation and Mitigation Strategy (REMS) program due to adverse drug reactions (ADRs) including nausea, dissociation, dizziness, and increases in blood pressure.

Objectives: The aim of this study was to examine reports of ADRs associated with esketamine.

Methods: Case reports of esketamine ADRs were identified using the FDA’s Adverse Event Reporting System (FAERS) database. Reports were limited to consumers in an effort to exclude clinical trial experience. Duplicate observations were eliminated by evaluating each case to all other reported cases by comparing reason for use, reaction reported, clinical outcome, patient gender, event date reported versus latest FDA received date, age, concomitant medications, and country where the event occurred. PubMed and Embase electronic databases were also searched for published case reports within the timeframe of January 2019-January 2020. Articles were reviewed to identify ADRs, patient demographic information, reason for use, clinical outcomes, and concomitant medications.

Results: The FAERS search identified 1582 potential cases and, within those, 272 consumer reported cases. Four duplicate cases were removed, leaving 268 cases for further analyses. The mean ± SD patient age was 48 ± 15 years. There were 76 males, 141 females, and 51 reports that did not specify patient gender. The most common clinically relevant ADRs reported were depression (28 cases), dissociation (20 cases), anxiety (15 cases), nausea (13 cases), and suicidal ideation (13 cases). Most cases were non-serious (69%), while 8% of cases were hospitalized and 3% expired. The most common reasons for use were depression (85 cases), depression + other reasons (19 cases), major depression (5 cases), and major depression + other reasons (5 cases). The top 10 concomitant medications were antidepressants or anxiolytics. Three case reports were identified from published literature which all reported ADRs of dissociation and vomiting.

Conclusions: This study found reported ADRs for esketamine were depression-related, with most being non-serious, but several deaths were reported. Many subjects were also taking other mental health therapies including other antidepressants and anxiolytics.