The FDA is now raising awareness regarding administration of tranexamic acid injections to be limited only to intravenous administration. There have been case reports where tranexamic acid was mistakenly injected neuraxially instead of intravenously, resulting in serious patient outcomes, including prolonged hospitalization and death.

Tranexamic acid injection is approved for short-term use (2–8 days) in patients with hemophilia to prevent or reduce bleeding and minimize the need for replacement therapy during and after tooth extraction. It should be administered intravenously by healthcare professionals only. The injection is available in single-dose ampoules or vials containing 1,000 mg/10 mL, marketed as Cyklokapron and in generic forms, as well as in single-dose IV bags containing 1,000 mg tranexamic acid in 100 mL sodium chloride solution.

FDA has required labeling changes for the prescribing information for tranexamic acid injections which include:

• Clearly mentioning potential risks related to inadvertent neuraxial administration of tranexamic acid injection.
• Statement indicating contraindication of neuraxial injection
• Dosage & administration preparation instruction regarding administering dilute form

The FDA recommends that tranexamic acid injection labels clearly display the product name and indicate its intravenous route of administration to prevent accidental neuraxial use. This aims to enhance safety and reduce the risk of serious medication errors.

Health care professionals should follow safe storage and handling practices. Tranexamic acid vials should not be kept near local anesthetics or in spinal or epidural kits. Medications should be stored with visible labels, not identified by cap color, and barcode scanning should be used when stocking or retrieving products. The drug should be stored separately or in locked bins outside operating rooms to prevent confusion.

For administration, the FDA advises using ready-to-infuse or pharmacy-prepared intravenous bags when possible, to avoid mix-ups with anesthetics. Labels and barcodes must always be checked before administration, and any prepared syringe should be labeled immediately unless used right away. When using spinal or epidural kits, all medication labels should be inspected carefully before use.

Health care facilities should add a clear “Contains Tranexamic Acid” warning label to all vials and ampules and include the drug on their high-alert medication lists. Policies and procedures should be implemented to ensure safe handling and minimize the risk of mix-ups. The FDA urges health care professionals and patients to report adverse events.

Learn more: FDA Provides Update to Health Care Professionals