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.