The Food and Drug Administration (FDA) has received reports of tranexamic acid injection being erroneously administered intrathecally in the perioperative setting instead of the intended intrathecal anesthetic (eg, bupivacaine injection) for neuraxial anesthesia.
Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. The product should be administered by intravenous route.
The FDA notes that the inadvertent intrathecal administration of tranexamic acid injection may result in serious life-threatening injuries, including seizures, cardiac arrhythmias, paraplegia, permanent neurological injury, and death. The similar appearance (eg, vial cap color and packaging) of tranexamic acid injection, bupivacaine injection and other products may contribute to the medication errors, along with the storage of these products in close-proximity to each other.
To address these medication errors, the FDA is revising the container labels and carton labeling of tranexamic acid injection to highlight the recommended intravenous route of administration. Additionally, the prescribing information of tranexamic acid injection will include stronger warnings regarding the risk of medication errors due to incorrect route of administration.
The FDA is advising health care professionals to consider the following when handling tranexamic acid injection:
- Store tranexamic acid injection separately from other drugs.
- Add an auxiliary warning label to note that the vial contains tranexamic acid.
- Check the container label to ensure the product is selected and administered.
- Utilize the barcode scanning when stocking medication cabinets and preparing or administering the product.
Adverse reactions may be reported to the FDA’s MedWatch program.
For more information visit fda.gov.
FDA alerts healthcare professionals about the risk of medication errors with tranexamic acid injection resulting in inadvertent intrathecal (spinal) injection. [press release]. Silver Spring, MD: US Food and Drug Administration; December 3, 2020.