Safety of Brexanolone in Adults with Postpartum Depression: Postmarketing Surveillance Data.

ABSTRACT:

Background

Brexanolone is currently the only medication approved by the US FDA for the treatment of postpartum depression (PPD) in patients ≥15 years. Brexanolone is available commercially only through a restricted program (ZULRESSO^® Risk Evaluation and Mitigation Strategy; REMS) due to risk of excessive sedation or sudden loss of consciousness during administration.

Objective

The aim of this analysis was to assess the postmarketing safety of brexanolone in adults with PPD.

Methods

The cumulative postmarketing adverse event (AE) listing from spontaneous and solicited individual case safety reports (ICSRs) received from March 19, 2019, through December 18, 2021, was analyzed. Clinical trial ICSRs were excluded. Reported AEs were classified as serious or nons

SUBMITTER: Garafola S 

PROVIDER: S-EPMC10491550 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature