Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27 – 30 October 2025 – www.ema.europa.eu

31 Ott, 2025

www.ema.europa.eu

New safety information for healthcare professionals  

Injectable tranexamic acid: serious adverse reactions when inadvertently given intrathecally

PRAC agreed on a direct healthcare professional communication (DHPC) to remind healthcare professionals that extreme caution should be taken when handling and giving injectable tranexamic acid to ensure it is only given intravenously (into a vein). It must not be given intrathecally (into the fluid-filled space between the thin layers that cover the brain and spinal cord), epidurally (into the space between the wall of the spinal canal and the covering of the spinal cord), intraventricularly (into a fluid-filled cavity in the brain) or intracerebrally (into the brain).

Tranexamic acid, which blocks the breakdown of blood clots, is used in adults and children from 1 year of age to prevent and treat bleeding.

PRAC reviewed cases of medication errors, including reports from across the EU, where injectable tranexamic acid was…

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