From the Guidelines
The most common complication of Tranexamic Acid (TXA) is not explicitly stated as one of the options provided (Acute Kidney Injury, Intracerebral Hemorrhage, or Pulmonary Embolism) in the most recent and highest quality evidence available. According to the most recent study 1, 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. 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.
Key Points to Consider
- TXA is an antifibrinolytic medication that works by inhibiting the breakdown of blood clots, making it useful for managing various bleeding conditions.
- The risk of complications from TXA is generally considered low, with no significant increase in thromboembolic events or other major complications observed in large meta-analyses 1.
- While acute kidney injury, pulmonary embolism, and intracerebral hemorrhage are potential complications of many medications and medical conditions, the evidence does not suggest that these are common complications of TXA specifically.
- The use of TXA should be guided by the clinical context, including the patient's underlying condition, the presence of any contraindications, and the potential for drug interactions.
Clinical Recommendations
- TXA should be used with caution in patients with pre-existing kidney disease or those at risk for renal impairment, as the risk of acute kidney injury may be increased in these populations, although this is not explicitly stated as a common complication in the provided evidence.
- Monitoring of kidney function and adjustment of dosing may be necessary in high-risk patients or during prolonged therapy.
- The potential benefits of TXA in reducing bleeding and improving outcomes should be weighed against the potential risks, which appear to be low based on the available evidence 1.
From the FDA Drug Label
5 WARNINGS AND PRECAUTIONS
- 1 Thromboembolic Risk 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.
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling: Thromboembolic Risk [see WARNINGS AND PRECAUTIONS (5.1)] ... 6. 2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of tranexamic acid. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure Gastrointestinal disturbances (nausea, vomiting, diarrhea) may occur and may resolve with dose-reduction. Allergic dermatitis and giddiness have been reported. Hypotension has been reported when intravenous injection is too rapid. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery, vein obstruction and cases associated with concomitant use of combination hormonal contraceptives) have been rarely reported in patients receiving tranexamic acid for indications other than hemorrhage prevention in patients with hemophilia
The most common complication of Tranexamic Acid among the given options is Pulmonary Embolism, as it is mentioned as one of the thromboembolic events that have been reported in patients treated with tranexamic acid 2 and also listed under postmarketing experience as a thromboembolic event 2. However, it's essential to note that the frequency of these events is not explicitly stated in the provided drug labels. Intracerebral Hemorrhage is also mentioned as a type of thromboembolic event, but Acute Kidney Injury is not directly mentioned as a common complication in the provided text, although acute renal cortical necrosis is listed, which is a different condition.
From the Research
Complications of Tranexamic Acid
The most common complication of Tranexamic Acid (TXA) is not explicitly stated in the provided studies as Acute Kidney Injury, Intracerebral Hemorrhage, or Pulmonary Embolism. However, the studies provide information on the potential risks associated with TXA:
- Pulmonary Embolism (PE) is mentioned as a potential risk in several studies 3, 4, 5, 6.
- The study by 3 found that among TXA recipients, 2.4% developed PE.
- The study by 4 describes a case of a woman who developed a new episode of PE after using TXA as a prophylactic measure.
- The study by 5 reports a case of a patient who developed a pulmonary embolism while on a prophylactic dose of TXA.
- The study by 6 found that TXA was not associated with a higher risk of thrombotic complications, including PE, within 30 days after surgery.
Comparison of Complications
While the studies do not provide a direct comparison of the complications, they suggest that:
- Pulmonary Embolism is a potential risk associated with TXA use 3, 4, 5, 6.
- There is limited information on the risk of Acute Kidney Injury and Intracerebral Hemorrhage associated with TXA use in the provided studies.
- The study by 6 found that TXA was associated with a higher risk of postoperative seizures, but this is not directly related to the complications mentioned in the question.
Summary of Findings
Based on the provided studies, Pulmonary Embolism is a potential complication of TXA use, but the risk of Acute Kidney Injury and Intracerebral Hemorrhage is not well-established in these studies 3, 4, 5, 6, 7.