Citation

Jin L, Yang K, Wu X, Zhang J. Expert Opin. Drug Saf. 2024; ePub(ePub): ePub.

Copyright

(Copyright © 2024, Informa Healthcare)

DOI

10.1080/14740338.2024.2387316

PMID

39093352

Abstract

BACKGROUND: Postpartum depression (PPD) is linked to hormonal changes. Brexanolone, the first FDA-approved drug for PPD, is a potential treatment. This study analyzes Brexanolone's safety using the FAERS database, highlighting its adverse effects and potential risk factors.

METHODS: We analyzed FAERS data from Q3 2019 to Q3 2023, evaluating adverse reactions to Brexanolone. The analysis includes demographics, reporting regions, reporter identities, and types of adverse reactions.

RESULTS: Most reports are from the United States, with consumers and physicians as primary reporters. Adverse reactions mainly involve severe systemic diseases, administration site reactions, injuries, intoxication, operational complications, and mental disorders. Specific adverse reactions include incorrect drug monitoring, PPD, intrusive thoughts, delayed treatment efficacy, sedation complications, product discontinuation, misuse, infusion site leakage and pain, and medication errors.

CONCLUSION: The study confirms known safety information about Brexanolone and provides comprehensive data for medical practices and public health decisions. However, relying on spontaneous reports may introduce biases and incomplete information. Continued monitoring and reporting of adverse reactions to newer drugs like Brexanolone remain crucial.

Language: en

Keywords

Brexanolone; FAERS database; postpartum depression (PPD); Safety analysis; side effects