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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Obstetric and Pediatric Pharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1491032

Safety evaluation of Medroxyprogesterone acetate: A pharmacovigilance analysis using FDA adverse event reporting system data

Provisionally accepted
Luyang SU Luyang SU 1REN XU REN XU 1*YANAN REN YANAN REN 1SHIXIA ZHAO SHIXIA ZHAO 1*WEILAN LIU WEILAN LIU 1*ZEQING DU ZEQING DU 2*
  • 1 Hebei General Hospital, Shijiazhuang, China
  • 2 Second Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China

The final, formatted version of the article will be published soon.

    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

    Keywords: Medroxyprogesterone Acetate, Real-world data analysis, Adverse drug events, FAERS, Unintended pregnancy

    Received: 04 Sep 2024; Accepted: 11 Nov 2024.

    Copyright: © 2024 SU, XU, REN, ZHAO, LIU and DU. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    REN XU, Hebei General Hospital, Shijiazhuang, China
    SHIXIA ZHAO, Hebei General Hospital, Shijiazhuang, China
    WEILAN LIU, Hebei General Hospital, Shijiazhuang, China
    ZEQING DU, Second Hospital of Hebei Medical University, Shijiazhuang, 050000, Hebei Province, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.