Nephrotoxicity of direct factor Xa inhibitors: a pharmacovigilance study using real-world data from the Federal Adverse Event Reporting System database.

Abstract

Background: Factor Xa inhibitors (FXaIs) may induce nephrotoxicity despite their FDA approval for thrombotic diseases, which has raised concerns due to its severe consequences. This study utilizes the FAERS database to assess the potential link between direct FXaIs and nephrotoxicity.

Methods: Data from the FAERS database, spanning from the third quarter of 2011 to the fourth quarter of 2023, were used to perform a disproportionality analysis on Apixaban, Edoxaban, and Rivaroxaban. Disproportionality analysis and statistical processing were conducted using R software.

Results: Descriptive analysis revealed that males and individuals aged 65-85 are more susceptible to nephrotoxic adverse events. The disproportionality analysis indicated that all three drugs are associated with acute renal failure and renovascular disorders, with Edoxaban showing the strongest correlation.

Conclusions: This study quantitatively analysed the relative risk of nephrotoxic adverse reactions associated with direct FXaIs, emphasizing the importance of renal function monitoring for these medications. The results indicate that Edoxaban has a significant association with nephrotoxicity, necessitating closer attention to its use and recommending additional renal function tests and drug concentration testing for high-risk patients.