Cases of medication errors have been identified internationally where tranexamic acid injection was inadvertently administered to the spinal cord (intrathecally or epidurally), resulting in severe pain, seizures, cardiac arrhythmias and deaths.
Injectable tranexamic acid should only be administered intravenously and must not be given intrathecally or epidurally.
Tranexamic acid is a clotting medicine that helps to control bleeding. Intravenous tranexamic acid is used during or after surgical procedures.
Most of the administration errors involved mix-ups of vials or ampoules resulting in administration of tranexamic acid instead of the intended injectable local anaesthetic (e.g., bupivacaine, levobupivacaine, prilocaine). At particular risk are procedures that may include intravenous injection of tranexamic acid along with intrathecally administered injectable products.
What health professionals should do
To minimise the risk, health professionals should consider taking preventative measures with both storage and administration of tranexamic acid.
It is highly recommended that syringes containing tranexamic acid be clearly labelled for intravenous use only. This will help to prevent any mix-ups during administration.
Additionally, it is advised that tranexamic acid injectables be stored separately from injectable local anaesthetics. This segregation will further reduce the risk of incorrect administration and enhance patient safety.
Background
The US Food and Drug Administration published an alert - external site in October last year after strengthening warnings to the Prescribing Information (PI) over this issue.
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee reviewed cases in which tranexamic acid was given intrathecally or epidurally that resulted in severe pain, seizures, cardiac arrhythmias and deaths. Following this review, they issued a Dear Healthcare Professional letter - external site to remind providers that tranexamic acid must not be administered intrathecally, epidurally, by intraventricular injection or by intracerebral application.
We reviewed the Australian PIs and found the wording was adequate and did not require updating, with the PIs stating that tranexamic acid is contraindicated for intrathecal or epidural use.
Disclaimer
Medicine Safety Updates are aimed at health professionals. They are intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicine Safety Updates is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.
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