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

Abstract

Objectives: Medroxyprogesterone acetate (MPA), a steroid progesterone, is widely used to treat endometriosis, menstrual disorders, and uterine bleeding in clinical practice. However, the safety profile of MPA requires comprehensive evaluation.

Methods: This study performed a retrospective analysis using real-world data extracted from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Case reports from 2003 to 2023 were analyzed using methods like reporting advantage ratio (ROR), proportional report ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and empirical Bayes geometric mean (EBGM).

Results: In the case reports spanning from 2003 to 2023, showed 26,437 adverse events (AEs) related to MPA, mostly in females (25,639). Disproportionality analysis identified 116 ADRs across 19 system organ class (SOC) levels, including expected AEs like 'female breast cancer'(n = 8717) and 'ovarian cancer' (n = 459). Unexpected AEs, such as 'acquired diaphragmatic eventration'(n = 3), were also noted.

Conclusion: Our study identifies potential new and unexpected ADR signals linked to MPA, which align with clinical observations. Additional research is necessary to confirm these associations and address previously unrecognized safety concerns. This research provides a novel and distinctive approach to exploring drug-related AEs.