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Data pharmacovigilance analysis of medroxyprogesterone-related adverse events in the FDA adverse event reporting

Xiaomeng Wang1, Jimei Wang2, Fang Liu3

  • 1Department of Obstetrics, The Affiliated Hospital of Qingdao University, Qingdao, China.

Expert Opinion on Drug Safety
|January 31, 2025
PubMed
Abstract

Insights

This study analyzed 26,437 adverse events (AEs) linked to medroxyprogesterone acetate (MPA). It identified new and unexpected drug safety concerns, highlighting the need for further research into MPA's comprehensive safety profile.

Area of Science:

  • Pharmacovigilance
  • Drug Safety
  • Real-World Evidence

Background:

  • Medroxyprogesterone acetate (MPA) is a widely used progestin for gynecological conditions.
  • Comprehensive evaluation of MPA's safety profile is crucial due to its clinical use.

Purpose of the Study:

  • To identify potential new adverse drug reactions (ADRs) associated with MPA.
  • To analyze the safety profile of MPA using real-world data.

Main Methods:

  • Retrospective analysis of 2003-2023 case reports from the FDA Adverse Event Reporting System (FAERS).
  • Utilized disproportionality analyses including ROR, PRR, BCPNN, and EBGM.

Main Results:

  • Identified 26,437 adverse events (AEs) related to MPA, predominantly in females.
  • Detected 116 ADRs across 19 system organ classes, including known events (e.g., breast cancer) and unexpected events (e.g., diaphragmatic eventration).

Conclusions:

  • The study signals potential new and unexpected ADRs for MPA.
  • Further research is required to confirm these findings and address emerging safety concerns.
Keywords:
FAERSMedroxyprogesteroneadverse drug reactionadverse eventreal-world data analysis

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