December 3, 2020
Audience: Healthcare Professionals
December 3, 2020 — The U.S. Food and Drug Administration is alerting health care professionals about the risk of inadvertent intrathecal administration of tranexamic acid injection. Intrathecal administration of tranexamic acid injection may result in serious life-threatening injuries, including seizures, cardiac arrhythmias, paraplegia, permanent neurological injury, and death. In most of the cases reported to FDA, tranexamic acid injection was erroneously administered instead of the intended intrathecal anesthetic (e.g., bupvicaine injection) for neuraxial anesthesia.
Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Health care professionals should administer tranexamic acid injection by the intravenous route. It is supplied in single-dose ampules and single-dose vials containing 1,000 mg tranexamic acid in 10 mL and is available as a generic drug product and under the proprietary name, Cyklokapron.
Tranexamic acid injection, bupivacaine injection and other products used in the perioperative setting may have a similar appearance, such as similar vial cap color or packaging that may contribute to the mix-ups. Other practice-level and facility-level contributing factors such as storing products with similar appearance in close-proximity may also contribute to these errors.
The FDA is taking action to address tranexamic acid injection medication errors. This includes revising the tranexamic acid injection container labels and carton labeling to highlight the recommended intravenous route of administration; and strengthening the warnings in the tranexamic acid prescribing information to include the risk of medication errors due to incorrect route of administration.
Careful handling of tranexamic acid injection is important to prevent medication errors that could result in serious injury or death. Health care professionals should consider the following steps:
- Store tranexamic acid injection vials separately from other drugs, in a way that makes the labels visible to avoid reliance on identifying drugs by the vial cap color.
- Add an auxiliary warning label to note that the vial contains tranexamic acid.
- Check the container label to ensure the correct product is selected and administered.
- Utilize barcode scanning when stocking medication cabinets and preparing or administering the product.
FDA encourages health care professionals and patients to report adverse events, medication errors, and quality problems experienced with the use of any medical product to MedWatch: The FDA Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
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