JADER Database-based Analysis of the Association Between Tranexamic Acid and Thromboembolism and Related Risk Factors.

BACKGROUND/AIM: Tranexamic acid (TXA) is widely used as a hemostatic agent and for various other indications, including dermatological and inflammatory conditions. However, its association with thromboembolism in the real-world setting remains unclear. In this study, we aimed to evaluate this association.

PATIENTS AND

METHODS

We collected data from the Japan Adverse Drug Event Report database from Q1 2004 to Q3 2020 and performed reporting odds ratio analyses and multivariate logistic regression analysis.

RESULTS

Overall, 1,735,923 reports were analyzed. TXA was the suspected causal drug in 54 cases of venous thromboembolism (VTE) and 8 cases of arterial thromboembolism. A significant signal was detected for VTE (reporting odds ratio=6.61; 95% confidence interval=5.03-8.70) but not for arterial thromboembolism. VTE cases involving TXA were more frequently reported in women and individuals with a body mass index of ≥25 than in other groups.

CONCLUSION

TXA may be associated with VTE. The findings highlight the importance of careful patient monitoring during TXA administration, particularly in high-risk populations such as women and individuals who are overweight.