Tranexamic acid and thrombosis

Tranexamic acid is an antifibrinolytic drug. It therefore reduces bleeding but, in certain situations, it may expose patients to a risk of thrombosis. It is used for the treatment of various types of bleeding, including menorrhagia, haematuria, certain surgical procedures and trauma. Its harm-benefit balance is favourable in certain situations associated with serious bleeding.The harm-benefit balance is different in minor bleeding: the expected benefits are smaller because the condition is not serious, and the risk of thromboembolism may be higher without the haemodilution associated with severe bleeding. Various drug regulatory agencies have received reports of thrombotic events attributed to tranexamic acid. In a case-control study using data from the British General Practice Research Database, women taking tranexamic acid had a 3-fold higher risk of developing deep vein thrombosis. There was a wide 95% confidence interval, ranging from 0.7 to 15.8; thus, a major increase in the risk of thrombosis cannot be ruled out. Only one comparative randomised trial assessed thrombotic events in 53 women receiving tranexamic acid for menorrhagia; too few patients were studied to determine the risk. 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. In practice, as of early 2013, the harm-benefit balance of tranexamic acidis favourable in severe traumatic bleeding. But when bleeding is not life-threatening, the thrombotic risk is too poorly documented to justify exposing patients to a plausible and inadequately evaluated risk.