Liver Injury with Ulipristal Acetate: Exploring the Underlying Pharmacological Basis.

ABSTRACT:

Introduction

The European Medicines Agency has suspended the use of ulipristal acetate (UPA) in the treatment of uterine fibroids and is reassessing its association with a risk of liver injury.

Objectives

Our objectives were to characterize the post-marketing reporting of drug-induced liver injury (DILI) with UPA and investigate the underlying pharmacological basis.

Methods

We queried the worldwide FDA Adverse Event Reporting System and performed a disproportionality analysis, selecting only hepatic designated medical events (DMEs) where UPA was reported as suspect. The reporting odds ratios (RORs) were calculated, and we considered a lower limit of the 95% confidence interval (LL95% CI) > 1 as significant. Physiochemical/pharmacokinetic features were extracted to ass

SUBMITTER: Gatti M 

PROVIDER: S-EPMC7686198 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature