[FDA Drug Safety Alert, December 3, 2020] – Intrathecal administration of tranexamic acid injection may result in serious life-threatening injuries, including seizures, cardiac arrhythmias, paraplegia, permanent neurological injury, and death. Reported cases included erroneous administration of tranexamic acid injection instead of the intended intrathecal anesthetic (e.g., bupivacaine injection) for neuraxial anesthesia.
Tranexamic acid injection, bupivacaine injection and other products used in the perioperative setting may have a similar appearance, such as similar vial cap color or packaging that may contribute to the mix-ups.
FDA recommends careful handling of tranexamic acid injection is important to prevent medication errors that could result in serious injury or death. Health care professionals should consider the following steps:
- Store tranexamic acid injection vials separately from other drugs, in a way that makes the labels visible to avoid reliance on identifying drugs by the vial cap color.
- Add an auxiliary warning label to note that the vial contains tranexamic acid.
- Check the container label to ensure the correct product is selected and administered.
- Utilize barcode scanning when stocking medication cabinets and preparing or administering the product.
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