November 25, 2025

The U.S. Food and Drug Administration (FDA) has issued a significant safety communication to healthcare professionals regarding the serious risk of inadvertent intrathecal (spinal) or epidural administration of tranexamic acid injection. The regulatory update highlights medication errors where tranexamic acid was incorrectly administered neuraxial instead of intended local anaesthetics, leading to severe patient harm, prolonged hospitalization, and fatalities.

To address these risks, the FDA is now requiring important labelling updates and providing facility-level safety measures to prevent such medication mix-ups.

Why This Update Matters

Tranexamic acid injection is approved only for intravenous (IV) administration and is mainly used for short-term management of bleeding in patients with haemophilia, including during and after dental procedures. However, due to similarities in packaging and storage conditions, mix-ups have occurred between tranexamic acid and local aesthetics used for spinal or epidural anaesthesia.

Such errors have resulted in life-threatening neurological effects, emphasizing the need for stronger labelling and safer medication-handling practices.

Key FDA-Required Labelling Changes

The FDA has mandated the following updates on all tranexamic acid injection products:

Regulatory Update

Purpose

Addition of a Boxed Warning

To highlight the critical risk of inadvertent neuraxial administration.

Clear Contraindication Statement

Explicitly stating the product must not be administered intrathecally or epidurally.

Revised Dosage & Administration Guidance

Reinforcing that IV administration only is permitted and including dilution instructions.

Enhanced Container Labelling

Ensuring product name and route of administration are visibly prominent.

These changes aim to improve clarity at the point of preparation and administration, reducing error risk.

Contributing Factors Leading to Medication Errors

Medication safety reviews indicated contributing human and system factors, such as:

  • Storing tranexamic acid near local aesthetics used for spinal/epidural procedures
  • Failure to verify product labelling before administration
  • Similar vial size or appearance causing product confusion
  • Lack of barcode scanning during medication selection

FDA-Recommended Safe Handling Practices

Storage Controls

  • Do not store tranexamic acid near spinal or epidural aesthetics.
  • Ensure labels are fully visible rather than relying on vial cap colour.
  • Use barcode verification during stocking and dispensing.
  • Store in separate, secured compartments or carts outside operating rooms.

Administration Practices

  • Prefer pre-prepared IV infusion bags to avoid confusion during manual preparation.
  • Always confirm the label before withdrawing medication.
  • Label syringes immediately after preparation.
  • Verify all medications included in spinal/epidural kits before use.

Facility Safety Enhancements

  • Apply “Contains Tranexamic Acid – IV Use Only” warning labels.
  • Add to high-alert medication lists in hospital safety protocols.
  • Implement multi-check verification workflows in critical care areas.

Conclusion

The FDA’s strengthened warnings reinforce the critical importance of medication verification, storage segregation, and clear labelling protocols in clinical environments. Healthcare facilities must ensure compliance to prevent potentially fatal medication errors.

At Maven Regulatory Solutions, we support pharmaceutical manufacturers, healthcare organizations, and regulatory teams in maintaining medication safety, labelling compliance, post-market surveillance, and risk mitigation strategies aligned with evolving FDA requirements.

Ensuring regulatory diligence is not just compliance—it is patient safety.