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

METHODS:

• Danish Nationwide historical prospective cohort (1996 to 2017)
• Participants
  • 15 to 49 years
  • Exclusions included: History of thromboembolism | Anticoagulation therapy | Thrombophilia | Cancer | Hypertension | Diabetes | Liver Disease
• Exposure
  • Use of oral TXA, as identified through filled prescriptions
• Study design
• Women followed until: End of the study period | Turned 50 years | Emigrated from country | Death | Experienced one of the exclusion criteria
• Primary outcomes
  • Venous thromboembolism (DVT or PE)  
  • Arterial thrombosis (MI or stroke)

RESULTS:

• 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)

CONCLUSION:

• 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

Learn More – Primary Sources:

Oral tranexamic acid and thrombosis risk in women

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