A systematic analysis of safety profile of Brexanolone in real-world use based on FAERS database

Objective: This study aims to analyze adverse events (AEs) associated with Brexanolone based on FAERS, to assess its real-world safety characteristics, and to explore potential underlying mechanisms. Methods: Data from the FAERS database since Brexanolone's approval in 2019 were extracted, categorizing and analyzing AEs based on frequency and signal strength. Signal detection was conducted using frequency and Bayesian methods to assess the statistical association between AEs and Brexanolone. Results: A total of 234 Brexanolone-related AE reports were collected. Signal detection results revealed a significant association between Brexanolone and multiple system-organ AEs. Intravenous infusion-related events were notably frequent, including Product Administration Error (35 cases), Incorrect Drug Monitoring Procedure (19 cases), Product Administration Interrupted (14 cases), Incorrect Product Administration Duration (11 cases), and Medication Error (10 cases). These findings indicate a need for more standardized management of Brexanolone administration in clinical practice. Common psychiatric AEs were identified, including Perinatal Depression, Intrusive Thoughts, Electroencephalogram Abnormality, Panic Disorder, Tearfulness, Self-Injurious Ideation, Sedation Complication, and Feelings of Despair. Of these, Tearfulness, Self-Injurious Ideation, Sedation Complication, Feelings of Despair, and Crying are known AEs of Brexanolone. Signal strengths for Perinatal Depression, Intrusive Thoughts, Electroencephalogram Abnormality, and Panic Disorder indicate new potential AEs. Conclusion: The introduction of Brexanolone has brought new hope to postpartum depression treatment, yet the study identifies a range of AEs, particularly associated with intravenous infusion and mental status changes, emphasizing caution in clinical application.