Does Oral TXA For Heavy Menstrual Bleeding Increase Thromboembolic Risk?
BACKGROUND AND PURPOSE:
Oral tranexamic acid (TXA) is used to manage heavy menstrual bleeding
In Denmark, oral TXA is used to manage acute bleeding, with levonorgestrel-releasing intrauterine system used for long-term management
Data on thromboembolic risks of oral TXA are limited
Meaidi et al. (EClinicalMedicine, 2021) assessed the association between oral TXA and the risk for venous thromboembolism and arterial thrombosis
Danish Nationwide historical prospective cohort (1996 to 2017)
15 to 49 years
Exclusions included: History of thromboembolism | Anticoagulation therapy | Thrombophilia | Cancer | Hypertension | Diabetes | Liver Disease
Use of oral TXA, as identified through filled prescriptions
Women followed until: End of the study period | Turned 50 years | Emigrated from country | Death | Experienced one of the exclusion criteria
Venous thromboembolism (DVT or PE)
Arterial thrombosis (MI or stroke)
2.0 million women followed | 13.8 million person-years
Women who filled TXA prescriptions: 3.2%
Incidence of primary outcome
Venous thromboembolisms: 3,392 cases
Arterial thromboses: 4,198 cases
Age-adjusted incidence rate of venous thromboembolism
TXA: 11.8 (95% CI, 4.6 to 30.2) per 10,000 person-years
Non-users: 2.5 (95% CI, 2.4 to 2.6) per 10,000 person-years
Adjusted incidence rate ratio: 4.0 (95% CI, 1.8 to 8.8)
Number needed to harm: 1 extra venous thromboembolism was diagnosed for every 78,549 women using oral tranexamic acid for five days
Age-adjusted incidence rate of arterial thrombosis
TXA: 3.4 (95% CI, 1.1 to 10.7) per 10,000 person-years
Non-users: 3.0 (95% CI, 2.9 to 3.1) per 10,000 person-years
Adjusted incidence rate ratio: 1.3 (95% CI 0.4 to 4.2)
Compares to non-use, the use of TXA was associated with a 4-fold increase in the incidence of venous thromboembolism but number needed to harm was very high
There was no significant link between TXA and incidence of arterial thrombosis
Limitations include lack of adjustment for BMI and smoking
The authors state
Despite the above-mentioned limitations, the study clearly demonstrates that in a population of healthy women, venous thromboembolism and arterial thrombosis are maximally very rare adverse events of temporarily, short-lasting use of oral tranexamic acid, which is comparable with the risk attached to use of combined oral contraception
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This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
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