FDA Provides Update to Health Care Professionals About Risk of Inadvertent Intrathecal (Spinal) Administration of Tranexamic Acid Injection

Dear AHVAP Members and Colleagues, 

The following message is being communicated to all AHVAP members at the request of our partners at the US Food and Drug Administration:

FDA is requiring labeling changes to strengthen the warnings that tranexamic acid injection should be administered only intravenously (into the vein). Tranexamic acid injection products are not to be administered intrathecally (into the spine) or as an epidural injection. FDA is taking this action after having identified and evaluated medication error cases of inadvertent neuraxial (intrathecal or epidural) administration of tranexamic acid. In these cases, tranexamic acid was erroneously administered neuraxially instead of the intended local anesthetic (e.g., bupivacaine, lidocaine, mepivacaine, and ropivacaine), which resulted in serious patient outcomes, including prolonged hospitalization and death.

Medical practice-level and facility-level human factors (e.g., storing tranexamic acid injection close to local anesthetics and failing to verify the product before administration) contributed to the medication errors.

Tranexamic acid injection is indicated for short-term use (2 to 8 days) in patients with hemophilia to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Health care professionals should only administer tranexamic acid injection by the intravenous route. Tranexamic acid injection is supplied in single-dose ampules and single-dose vials containing 1,000 mg tranexamic acid in 10 mL and is marketed both under the proprietary name, Cyklokapron, and as a generic drug. Tranexamic acid is also supplied in sodium chloride injection in single-dose bags containing 1,000 mg of tranexamic acid in 100 mL solution for intravenous use.

FDA is requiring the following changes to the prescribing information for tranexamic acid injection:

• Add a Boxed Warning to communicate the risk of medication errors involving inadvertent neuraxial administration of tranexamic acid injection
• Add a statement to indicate that tranexamic acid injection is contraindicated as a neuraxial injection
• Update the Dosage and Administration section to clarify that tranexamic acid injection is only to be administered intravenously and to provide instructions for preparing and administering the diluted solution

Additionally, FDA is recommending that the container labels for tranexamic acid injection prominently display the product name and intravenous route of administration.

Health care professionals should consider the following steps to minimize the risk of inadvertent neuraxial administration of tranexamic acid injection:

Storage

• Do not store tranexamic acid injection vials or ampules near local anesthetics or in kits containing local anesthetics intended for spinal or epidural anesthesia.
• Store medication vials in a way that makes the labels visible to avoid reliance on identifying drugs by the vial cap color.
• Use barcode scanning when stocking medication cabinets to ensure the correct medication is placed in the appropriate storage bin.
• Store tranexamic acid injection vials and ampules in separate carts outside the operating room or in locked bins that require barcode scanning to remove from the bin.

Administration

• Use commercially available or pharmacy-prepared intravenous infusion bags of tranexamic acid, when possible, to minimize confusion with local anesthetics supplied in vials or ampules.
• Use barcode scanning and always check the container label to ensure the correct product is selected and administered.
• If withdrawing tranexamic acid injection from a vial or ampule, promptly label each syringe when it is prepared unless it is immediately administered.
• If using pre-packaged spinal or epidural kits, carefully inspect the container labels of medications included in the kit to verify the intended medication before use.

Additional Recommendations for Health Care Facilities

• Add a prominent "contains tranexamic acid" auxiliary warning label to all vials and ampules that contain tranexamic acid injection.
• Add tranexamic acid injection to internal high-alert medication lists and develop procedures and policies to ensure safe use and minimize the risk of mix-up with other medications.

FDA encourages health care professionals and patients to report adverse events, medication errors, and product quality problems experienced with the use of any medical product to MedWatch: The FDA Safety Information and Adverse Event Reporting Program:

1. Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
2. Download and complete the form, then submit it via fax at 1-800-FDA-0178.

As additional updates are communicated from our partners at FDA, we will pass them along as part of your AHVAP membership. 

Warm regards,

Team AHVAP