Fatal mix-ups between tranexamic acid and spinal anaesthetics have prompted a strong safety warning by the European Medicines Agency (EMA), urging healthcare professionals to ensure the drug is administered only intravenously to prevent life-threatening neurotoxicity.
Last year the South African Health Products Regulatory Authority (SAHPRA) also issued a warning related to several cases worldwide where tranexamic acid has been administered intrathecally in error instead of local anaesthetic agent bupivacaine – with fatal consequences – urging a change in packaging, among other measures, to reduce the likelihood of confusion.
In the latest alert, Medscape reports that in instances across the European Union, tranexamic acid was mistakenly injected into or near the spinal canal – intrathecally, epidurally, or intracerebrally – resulting in severe adverse reactions and, in some instances, death.
Communication vital for proper use
The warning follows a review by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which reiterated that errors occurred when tranexamic acid was confused with local anaesthetics typically used during spinal or epidural procedures.
Intrathecal use led to intense pain, in the back, buttocks, and legs, along with seizures and irregular heart rhythms.
An antifibrinolytic agent, tranexamic acid is used in adults and children aged 12 months or older to prevent and treat bleeding by blocking the breakdown of blood clots. When administered intravenously as indicated, it is safe and effective.
However, intrathecal or epidural administration can be lethal, as the drug becomes highly neurotoxic because it directly irritates neurons and nerve roots in the cerebrospinal fluid. By blocking inhibitory neurotransmitter receptors (GABAA and glycine), it induces severe neuronal hyperexcitability.
The lack of a definitive treatment protocol further increases the risk.
To reinforce correct use, PRAC has agreed on a direct healthcare professional communication (DHPC) reminding clinicians to exercise extreme care when handling and administering injectable tranexamic acid.
The communication also reiterates that the drug must never be administered intrathecally, epidurally, intraventricularly, or intracerebrally.
Clinicians are advised to clearly label syringes containing tranexamic acid as “for intravenous use only” and store the drug separately from local anaesthetics to prevent mix-ups during procedures.
Hospitals should also review labelling, storage, and staff training protocols to reduce the likelihood of error. The product information and outer packaging for all injectable formulations will be updated to emphasise intravenous use only.
Once adopted by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, the DHPC will be distributed to healthcare professionals by marketing authorisation holders and published on the EMA’s site and in national registers in EU Member States.
Medscape article – Mix-ups spur EMA alert on tranexamic acid
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SAHPRA flags fatal error linked to IV tranexamic acid
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