PRAC views serious adverse reactions with injectable tranexamic acid

The European Medicines Agency’s Pharmacovigilance Risk Committee (PRAC) has 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).

The off-patent drug 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.