⛔ FDA Black Box Warning
WARNING: RISK OF MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION Tranexamic acid injection is for intravenous use only. Serious, including fatal, adverse reactions including seizures and cardiac arrythmias have occurred when tranexamic acid injection was inadvertently administered via the neuraxial route [see Warnings and Precautions (5.1)]. WARNING: RISK OF MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION See full prescribing information for complete boxed warning. Tranexamic acid injection is for intravenous use only. Serious, including fatal, adverse reactions including seizures and cardiac arrythmias have occurred when tranexamic acid injection was inadvertently administered intrathecally via the neuraxial route. (5.1)
Contraindications
4 CONTRAINDICATIONS Tranexamic acid is contraindicated: In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid in such patients. In patients with active intravascular clotting [see WARNINGS AND PRECAUTIONS (5.1)]. In patients with hypersensitivity to tranexamic acid or any of the ingredients [see WARNINGS AND PRECAUTIONS (5.4)].
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. There are 2 (0.02%) infant cases with structural abnormalities that resulted in death when tranexamic acid was used during conception or the first trimester of pregnancy; however, due to other confounding factors the risk of major birth defects with use of tranexamic acid during pregnancy is not clear. Tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration (see Data). Reproduction studies performed in mice, rats, and rabbits have not revealed any adverse effects on the fetus due to tranexamic acid administered during organogenesis. Doses examined were multiples of up to 3 times (mouse), 6 times(rat), and 3 times (rabbit) the maximum human dose based on body surface area in the mouse, rat, and rabbit, respectively (see Data). The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2-4% and 15-20%, respectively. It is not known whether tranexamic acid use in pregnant women may cause a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. For decisions regarding the use of Tranexamic Acid in Sodium Chloride Injection during pregnancy, the potential risk of Tranexamic Acid in Sodium Chloride Injection administration on the fetus should always be considered along with the mother’s clinical need for Tranexamic Acid in Sodium Chloride Injection; an accurate risk-benefit evaluation s