What is the risk of prothrombotic events with Tranexamic acid (TXA) dosage?

From the Guidelines

Tranexamic acid does not appear to increase the risk of thromboembolic complications, and its use is generally considered safe, as evidenced by a meta-analysis of 216 trials 1. When considering the use of tranexamic acid, it is essential to weigh the benefits of reduced bleeding against the potential risks. The majority of the evidence suggests that tranexamic acid is not associated with an increased risk of thromboembolic complications 1. Some key points to consider when using tranexamic acid include:

• A meta-analysis of 216 trials (125,550 participants) found no evidence of an increased risk of thromboembolic complications associated with the use of tranexamic acid 1.
• Another meta-analysis focusing on patients undergoing non-cardiac surgery (191 RCTs, 40,621 participants) also found no evidence of an increased risk of cardiovascular thromboembolic complications, seizures or mortality at 30 days with tranexamic acid use 1.
• Tranexamic acid should be used with caution in patients, particularly those with pre-existing risk factors for thrombosis.
• A suggested dosing schedule for different clinical indications is provided, and it is crucial to follow this schedule to minimize potential risks. It is also important to note that tranexamic acid works by inhibiting plasminogen activation and fibrinolysis, which stabilizes clots but can potentially promote thrombosis, especially in patients with hypercoagulable states, history of venous thromboembolism, or those on estrogen therapy. However, the current evidence does not support a significant prothrombotic risk associated with tranexamic acid use, and it can be used safely in most patients, as long as the recommended dosing schedule is followed 1.

From the FDA Drug Label

Tranexamic acid is contraindicated in patients with active intravascular clotting. Tranexamic acid is an antifibrinolytic and may increase the risk of thromboembolic events. Venous and arterial thrombosis or thromboembolism has been reported in patients treated with Tranexamic acid Avoid concomitant use of Tranexamic acid and medical products that are pro-thrombotic, as the risk of thrombosis may be increased.

The use of tranexamic acid may increase the risk of thromboembolic events, including venous and arterial thrombosis or thromboembolism. It is contraindicated in patients with active intravascular clotting and its use should be avoided with other pro-thrombotic medications. 2

From the Research

Tranexamic Acid and Prothrombotic Risk

• The use of tranexamic acid has been associated with a potential risk of thrombosis, particularly in certain situations such as minor bleeding 3.
• However, clinical trials conducted in serious haemorrhage or in patients undergoing surgery with a high risk of bleeding have not shown an increased risk of thrombosis with tranexamic acid 3.
• A systematic review and meta-analysis of 216 studies found no association between intravenous tranexamic acid and increased risk of thromboembolic events, including venous thrombosis, pulmonary embolism, and cerebral infarction 4.
• Another study found that tranexamic acid administration was not associated with an increase in complications, including thrombotic events, in high-risk patients undergoing primary total knee or total hip arthroplasty 5.

Dosage and Risk of Thrombosis

• The risk of thrombosis associated with tranexamic acid may be related to the dosage used, with higher doses potentially increasing the risk of adverse effects 6.
• However, a meta-regression analysis found no association between tranexamic acid dosing and risk of venous thromboembolic events 4.
• The optimal dosage and administration regimen for tranexamic acid are still being evaluated and reviewed to improve its safety and effectiveness 6.

Clinical Use and Controversies

• Tranexamic acid is commonly used for the treatment or prevention of bleeding in various clinical settings, including heavy menstrual bleeding, trauma, and surgical site bleeding 7.
• Despite its widespread use, controversies surrounding tranexamic acid persist, including concerns about the risk of thrombosis and its use in patients with certain medical conditions 7.
• Further research and evidence are needed to fully understand the benefits and risks of tranexamic acid and to address the controversies surrounding its use 3, 6, 4, 5, 7.