Written By: Dr. Nevethaa Natraj, PharmD
Assisted By: Abhinay Wadekar, BPharm
Reviewed By: Pharmacally Editorial Team
In a busy operating room, a 68-year-old woman was having knee surgery. The surgeon planned to use tranexamic acid to wash the knee and reduce bleeding. Meanwhile, the anesthesiologist planned to give a spinal injection with bupivacaine and morphine for pain relief. Both medicines came in 10-mL vials that looked very similar. In the rush, the anesthesiologist picked up the tranexamic acid vial instead of bupivacaine without closely checking the label. There was no barcode scan to catch the mistake. When the tranexamic acid was injected into the spine, the woman suddenly had seizures and uncontrollable muscle jerks. The surgery was stopped, and she was treated in intensive care with medicines to stop her seizures and help her breathe. After three weeks in the hospital, she was moved to a nursing facility to recover.
Following multiple reports of serious medication errors like this involving tranexamic acid mistakenly given into the spine instead of local anesthetics, leads to recent FDA’s boxed warning to all tranexamic acid injection products.
In October 2025, the U.S. Food and Drug Administration (FDA) issued a critical safety update addressing the severe risk of inadvertent intrathecal (spinal) administration of Tranexamic Acid (TXA) Injection. This action followed accumulating reports of catastrophic medication errors where TXA, intended for intravenous use, was mistakenly injected into the spinal canal. These errors resulted in multiple cases of severe neurological injury, cardiac arrest, and even death. The FDA’s updated safety communication emphasizes the urgent need for enhanced warnings, boxed labeling, and safer medication handling practices among marketing authorization holders (MAHs) and healthcare providers.
Observations Leading to FDA Action
The FDA reviewed numerous case reports and safety surveillance data documenting instances of wrong-route administration of TXA. Common observations included: TXA being erroneously injected intrathecally instead of local anesthetics used for spinal or epidural anesthesia. These wrong-route errors caused seizures, permanent neurological damage including paraplegia, cardiac abnormalities, and high fatality rates in affected patients. Over half of such reported cases led to death or prolonged hospitalization. Medication errors were frequently linked to TXA ampules being stored near or mistaken for spinal anesthetics.
A key factor contributing to these tragic medication errors has been the look-alike, sound-alike (LASA) confusion between tranexamic acid injection commonly marketed as Cyklokapron and local anesthetics such as bupivacaine (brand name Marcaine) and ropivacaine. These medications are often stored in similar-looking vials with comparable volume and cap color, leading to mix-ups during preparation in the operation theatre. Several reported cases documented anesthesiologists inadvertently selecting tranexamic acid vials believing they were bupivacaine and administering TXA intrathecally instead of the intended spinal anesthetic. This error caused immediate neurological symptoms, including seizures, myoclonus, ventricular arrhythmias, and in many cases, fatal outcomes. Investigations revealed that improper storage within the same medication drawer, confirmation bias during vial selection, and lack of barcode scanning contributed to these mistakes.
The Actual Issue with Tranexamic Acid Injection
Tranexamic Acid is a synthetic antifibrinolytic agent primarily used intravenously to reduce bleeding during surgeries or trauma. While it is lifesaving when used correctly, TXA is neurotoxic if administered intrathecally due to its potent inhibitory effects on central nervous system neurotransmission. This off-route administration causes seizures, irreversible neurological injury, cardiovascular collapse, and death. There is no safe off-label intrathecal use of TXA.
FDA Recognition of the Issue
The FDA detected this safety risk via cumulative medication error reports, post-marketing surveillance, and adverse event notifications submitted by healthcare facilities and pharmacovigilance programs. Both case reports and observational data underscored a pattern of fatal outcomes linked to inadvertent neuraxial administration of TXA, highlighting an urgent need for regulatory intervention. This was not a single study but a compilation of real-world medication error cases.
Detailed FDA Actions Taken
The FDA mandated several corrective and preventive measures for all marketing authorization holders (MAHs) of TXA injections:
Introduction of a prominent Boxed Warning on TXA product labeling explicitly alerting against intrathecal or epidural administration
Updated Contraindications and Dosage & Administration sections in prescribing information, highlighting intravenous-only use
Requirement for clear, prominent labeling on vials and ampules including “IV Use Only” and a bold display of the drug name to prevent confusion.
Issuance of safety communications and healthcare professional alerts to raise awareness of the risk and recommended handling
Healthcare facilities are advised to add a prominent auxiliary warning label stating “contains tranexamic acid” on all vials and ampules of tranexamic acid injection to enhance visual identification and prevent confusion with other medications.
Tranexamic acid injection should be included in the hospitals internal high-alert medication lists. Facilities must develop and implement specific procedures and policies aimed at ensuring the safe use of tranexamic acid.
Storage Recommendation
Tranexamic acid vials or ampules should not be stored near local anesthetics such as bupivacaine or in kits containing local anesthetics intended for spinal or epidural anesthesia.
It is recommended to store medication vials in a manner that makes the labels clearly visible, avoiding reliance solely on vial cap color for identification.
Advocation for use of barcode medication administration systems and enhanced staff training to prevent such errors at the point of care
Use of barcode scanning technology is strongly encouraged when stocking medication cabinets and preparing medications, ensuring that the correct medication is placed in designated storage bins
Tranexamic acid vials and ampules should be stored in separate carts outside the operating room or in locked bins that require barcode scanning for removal. These measures aim to minimize LASA errors and improve medication safety in perioperative settings.
Administration Recommendations
Whenever possible, use commercially available or pharmacy-prepared intravenous infusion bags of tranexamic acid to reduce confusion with local anesthetics supplied in vials or ampules.
Always use barcode scanning and carefully check the container label to confirm the correct product is selected before administration.
If tranexamic acid is withdrawn from a vial or ampule into a syringe, promptly label the syringe unless it will be administered immediately.
When using pre-packaged spinal or epidural kits, carefully inspect the medication labels in the kit to verify the intended medication before use
Implementation and Monitoring
FDA will monitor compliance among MAHs through their regular inspection processes and require periodic safety reports from product holders. The agency will collaborate with healthcare institutions to track medication errors related to TXA administration and evaluate the effectiveness of new labeling and storage guidelines. Additionally, ongoing pharmacovigilance programs will actively review adverse events reported via FDA’s Med Watch system to identify any recurrence of wrong-route injections
What Health-Care Professionals Should Know and Do
Physicians and anesthesia providers must:
Strictly adhere to intravenous administration of Tranexamic Acid.
Be vigilant about medication storage ensure TXA ampules are physically separated from spinal anesthetics.
Educate all clinical staff on the severe risks of intrathecal TXA and the updated FDA boxed warnings.
Confirm patient and drug identification prior to administration using barcode scanning or double-check systems.
Monitor patients closely for any adverse neurological symptoms post-TXA use and report any errors promptly.
What Patients Should Know
Patients receiving TXA infusions should be informed that:
TXA is safe and effective when given intravenously as prescribed.
Inadvertent administration into the spinal canal is extremely dangerous and has been linked to severe adverse events.
They should alert healthcare providers immediately if they experience unusual neurological symptoms such as seizures or weakness after treatment.
Public Health Implications
This FDA safety update emphasizes the need for strong healthcare system protocols to prevent medication errors causing severe harm. It highlights the critical importance of clear drug labeling, safe medication storage, staff training, and patient safety awareness. By reducing these errors, patient morbidity and mortality related to surgical bleeding management will be minimized, improving overall healthcare quality and trust.
Key Opinions from Officials and Health Experts
FDA officials stressed that “the issuance of this boxed warning is a vital intervention to prevent fatal medication errors involving TXA” and urge all stakeholders to implement recommended safeguards. Clinical toxicologists and anesthesiologists emphasize the need for increased awareness in operating rooms and intensive care units to avoid tragic outcomes. Experts believed that ongoing education, barcode technologies, and system-level checks are needed to reinforce patient safety culture.
References
FDA Provides Update to Health Care Professionals About Risk of Inadvertent Intrathecal (Spinal) Administration of Tranexamic Acid Injection, 21 October 2025, US FDA, https://www.fda.gov/drugs/drug-safety-and-availability/fda-provides-update-health-care-professionals-about-risk-inadvertent-intrathecal-spinal
FDA Alerts Healthcare Professionals about the Risk of Medication Errors with Tranexamic Acid Injection Resulting in Inadvertent Intrathecal (Spinal) Injection, 10 Feb 2025, US FDA, https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-healthcare-professionals-about-risk-medication-errors-tranexamic-acid-injection-resulting
The United States: FDA provides update to healthcare professionals about risk of inadvertent intrathecal (spinal) administration of tranexamic acid injection, Drug Office, Department of Health, The Government of the Hong Kong Special Administrative Region, https://www.drugoffice.gov.hk/eps/news/showNews/The+United+States:+FDA+provides+update+to+healthcare+professionals+about+risk+of+inadvertent+intrathecal+(spinal)+administration+of+tranexamic+acid+in/pharmaceutical_trade/2025-10-22/en/56276.html
Simoes Ferreira D, Dias C, Costa L, Bettencourt M. Right Drug in the Wrong Place: The Effects of Inadvertent Intrathecal Tranexamic Acid. Cureus. 2024 Oct 29; 16(10):e72661. Doi: 10.7759/cureus.72661. PMID: 39610631; PMCID: PMC11604296.
Risk of medication errors with tranexamic acid injection resulting in inadvertent intrathecal injection, World Health Organization, 16 March 2025, https://www.who.int/news/item/16-03-2022-risk-of-medication-errors-with-tranexamic-acid-injection-resulting-in-inadvertent-intrathecal-injection
Dangerous Wrong-Route Errors with Tranexamic Acid-A Major Cause for Concern, 23 May 2025, Institute for Safe Medication Practices, https://home.ecri.org/blogs/ismp-alerts-and-articles-library/dangerous-wrong-route-errors-with-tranexamic-acid-a-major-cause-for-concern
Grissinger M. Key Vulnerabilities in the Surgical Environment: Container Mix-Ups and Syringe Swaps. P T. 2018 Mar;43(3):129-167. PMID: 29491691; PMCID: PMC5821235,
Paul A. Lefebvre, Unraveling a Recurrent Wrong Drug-Wrong Route Error—Tranexamic Acid in Place of Bupivacaine: A Multistake holder Approach to Addressing this Important Patient Safety Issue, Anesthesia Patient Safety Foundation, apsf Newsletter, Volume 39, No. 2, June 2024, https://www.apsf.org/article/unraveling-a-recurrent-wrong-drug-wrong-route-error-tranexamic-acid-in-place-of-bupivacaine/