A retrospective research of adverse event reporting system events for voxelotor based on the FAERS database.

ABSTRACT:

Background

Sickle cell disease (SCD) is a severe genetic disorder causing anemia, pain, and organ damage, affecting millions globally. Voxelotor, approved in the United States in 2019, targeted sickle cell disease pathophysiology. Despite its therapeutic benefits, concerns remain regarding its long-term safety and potential side effects, including headaches and gastrointestinal disturbances. This study used the FDA Adverse Event Reporting System (FAERS) to assess voxelotor's safety, aiming to enhance treatment strategies and clinical decision-making in SCD management.

Methods

In this study, we utilized the FAERS to extract voxelotor-related adverse event reports from 2019 to 2024. We conducted descriptive and disproportionality analyses using four algorithms: Reporting Odds

SUBMITTER: Lin Y 

PROVIDER: S-EPMC11969824 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature