Tranexamic acid: risk of serious adverse events after inadvertent spinal administration

Summary

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 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 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.

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Medicines Safety Update is written by staff from the Pharmacovigilance Branch.