Fatal mix-ups between tranexamic acid and spinal anesthetics 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.

In cases reported across the European Union, the drug was mistakenly injected into or near the spinal canal — intrathecally, epidurally, or intracerebrally — resulting in severe adverse reactions and, in some instances, death.

Communication for Proper Use

The warning follows a review by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which found that several errors occurred when tranexamic acid was confused with local anesthetics 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.

Tranexamic acid is an antifibrinolytic agent used in adults and children aged 1 year 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 (GABA_A 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.

Updated Safety Measures 

Clinicians are advised to clearly label syringes containing tranexamic acid as “for intravenous use only” and store the drug separately from local anesthetics to prevent mix-ups during procedures. Hospitals should also review labeling, 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 emphasize intravenous use only. 

Once adopted by the Coordination Group for Mutual Recognition and Decentralised Procedures - Human, the DHPC will be distributed to healthcare professionals by marketing authorization holders and published on the EMA’s site and in national registers in EU Member States.