Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) – 27-30 October 2025:

Injectable tranexamic acid

• Safety issue: Cases of medication errors have been reviewed in which tranexamic acid was mistakenly administered intrathecally or epidurally, due to confusion with other medications, particularly local anesthetics. Patients experienced serious adverse reactions, including severe pain localized to the back, buttocks, and lower limbs, seizures, cardiac arrhythmias, and, in some cases, death.
• Communications/Recommendations: The PRAC recommends to disseminate Direct Healthcare Professionals Communication (DHPC) about the use of injectable tranexamic acid in order to prevent such errors, reminding that the medicine should only be administered intravenously. The PRAC also recommends to clearly label syringes with the words "for intravenous use only" and storing tranexamic acid separately from local anaesthetics.