Pharmacovigilance study on old drugs repurposed for rare diseases across different indications: the case of fenfluramine.

ABSTRACT:

Objective

As an old drug with a new application in rare diseases with epileptic symptoms, fenfluramine may have potential unrecognized adverse events. Because limited real-world data exist on Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) populations, some rare adverse events (AEs) are easily overlooked. The purpose of this study was to comprehensively evaluate the characteristics of adverse events of fenfluramine.

Methods

The data were extracted from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database from the third quarter of 2020 to the fourth quarter of 2024 for data cleaning and analysis. To ensure the accuracy and reliability of the study, adverse events of fenfluramine were analyzed using the Reporting Odds Ratio (ROR), Bayes

SUBMITTER: Zhong J 

PROVIDER: S-EPMC12504265 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature