Tranexamic acid is an antihaemorrhagic agent which inhibits the breakdown of fibrin clots. It is licensed for the prevention and treatment of haemorrhages due to general or local fibrinolysis, with specific indications including menorrhagia, epistaxis, conisation of the cervix, traumatic hyphaema, hereditary angioneurotic oedema, and to minimise blood loss following bladder surgery and dental extraction in patients with haemophilia.
The available data concerning the fetal effects of gestational tranexamic acid exposure are highly limited. These data currently consist of 12 case reports/series and two small randomised controlled trials which describe the outcomes of 230 exposed pregnancies, the majority of which are thought to have been exposed acutely in late pregnancy.
No cases of congenital malformation have been reported among the small number of pregnancies exposed in early pregnancy, and no cases of intrauterine death have been reported among those exposed in later pregnancy. Miscarriage, preterm delivery, low infant birth weight and neonatal complications have been sporadically described following tranexamic acid exposure. However, the underlying maternal illness which necessitated tranexamic acid use may have contributed to these outcomes.
Theoretical concerns exist regarding an increased risk of venous thrombosis following tranexamic acid use in pregnancy, and maternal thrombosis and/or pulmonary embolism have been reported in a small number of exposed pregnancies. However, controlled epidemiological studies do not currently provide supportive evidence of an increased risk of maternal thrombosis following tranexamic acid exposure in pregnancy.
Exposure to tranexamic acid at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.