Tranexamic acid intravenous formulations - Serious including fatal adverse reactions due to inadvertent intrathecal administration.

Intravenous formulations of tranexamic acid must be administered exclusively via the IV route. Use through other routes, such as intrathecal, epidural, intraventricular, or intracerebral, is contraindicated.

Serious adverse events, including fatal cases, have been reported following accidental intrathecal administration, often due to confusion with injectable local anesthetics.

Therefore, the following measures are recommended:

• Maximum care in the storage, preparation, and administration of the medicinal product.
• Clear labeling of syringes intended for IV use.
• Separate storage of tranexamic acid from local anesthetics to reduce the risk of errors.

Further information is provided in the related document.

Healthcare professionals are reminded of the importance of reporting suspected adverse reactions to ensure continuous monitoring of medicinal product safety and to protect patient health.