AUTHOR=Su Luyang , Xu Ren , Ren Yanan , Zhao Shixia , Liu Weilan , Du Zeqing 

TITLE=Safety evaluation of medroxyprogesterone acetate: a pharmacovigilance analysis using FDA adverse event reporting system data

JOURNAL=Frontiers in Pharmacology

VOLUME=Volume 15 - 2024

YEAR=2024

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1491032

DOI=10.3389/fphar.2024.1491032

ISSN=1663-9812

ABSTRACT=Background: Medroxyprogesterone acetate (MPA), a synthetic progestogen, is extensively used for the treatment of various conditions, including contraception, irregular menstruation, functional uterine bleeding, and endometriosis. However, like all pharmaceutical agents, MPA is associated with adverse drug reactions. This study aimed to evaluate the adverse events (AEs) associated with MPA in by analyzing real-world data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS). By providing a comprehensive assessment of the safety profile of MPA, this study seeks to support informed clinical decision-making.Methods: Data covering the period from the first quarter of 2004 to the first quarter of 2024 were collected from the FAERS database. Disproportionality analyses were conducted using several statistical methods, including reporting odds ratio (ROR), proportional reporting ratio (PRR), empirical Bayesian geometric mean (EBGM). Additionally, time-to-onset (TTO) analysis was employed to quantify the signals of the MPA-associated AEs.Results: A comprehensive dataset comprising 21,035,995 AE reports was compiled. Among these, 3,939 women reported using MPA as a contraceptive method. The reports covered 27 system organ classes (SOCs) and 25 high-frequency AE signals. Notably, significant AEs were identified, some of which were not previously detailed in the medication's prescribing information. Unforeseen