Advertisement
Full length article| Volume 279, P195-198, December 01, 2022

Tranexamic acid at cesarean delivery: drug-error deaths

Published:October 21, 2022DOI:https://doi.org/10.1016/j.ejogrb.2022.09.016
Tranexamic acid at cesarean delivery: drug-error deaths
Previous ArticleThe Greek version of the Australian Pelvic Floor Questionnaire: Cross-cultural adaptation and validation amongst women with urinary incontinence
Next ArticleSome concerns about epidural anaesthesia, propensity score matching and anaesthesiologists

      Abstract

      The use of tranexamic acid for postpartum hemorrhage has entered obstetrical practice globally with the evidence-based expectation of saving lives. This improvement in the care of women with postpartum hemorrhage has come at a price. For the anesthetist, having tranexamic acid ampoules close at hand would seem an obvious strategy to facilitate its use during cesarean delivery, an important setting for severe hemorrhage. Tragically, we have identified a number of recent instances of inadvertent intrathecal administration of tranexamic acid instead of local anesthetic for spinal anesthesia. Reported cases of this catastrophic error seem to be increasing. The profound neurotoxicity of tranexamic acid causes rapid-onset convulsions, with mortality of 50%.
      How can these tragic errors be averted? Drug safety alerts have been issued by the US Food and Drug Administration and the World Health Organization, but that is not enough. We recommend extensive dissemination of information to raise awareness of this potential hazard, and local hospital protocols to ensure that tranexamic acid is stored separately from anesthetic drugs, preferably outside the operating room and with an auxiliary warning label. Implementation of safety strategies on a very large scale will be needed to ensure that the life-saving potential of tranexamic acid is not eclipsed by drug-error mortality.

      Keywords

      Abbreviations:

      PPH (Postpartum hemorrhage)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to European Journal of Obstetrics and Gynecology and Reproductive Biology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Register: Create an account
      Institutional Access: Sign in to ScienceDirect

      References

      1. World Health Organization. WHO recommendation on tranexamic acid for the treatment of postpartum haemorrhage. 2017. Available at: https://www.who.int/publications/i/item/9789241550154. Accessed March 28, 2022.

        View in Article
        • Shakur H.
        • Roberts I.
        • Fawole B.
        • Chaudhri R.
        • El-Sheikh M.
        • Akintan A.
        • et al.
        Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial.
        Lancet. 2017; 389: 2105-2116
        View in Article

      3. National Department of Health, South Africa. Essential Drugs Programme. Hospital level (Adults) Standard Treatment Guidelines and Essential Medicines List. 5th ed. 2019. Published and funded by: The National Department of Health, Pretoria, Republic of South Africa. Available at: https://www.knowledgehub.org.za/system/files/elibdownloads/2020-07/Hospital%20Level%20%28Adult%29%202019_v2.0.pdf5-0 Accessed March 28, 2022.

        View in Article
        • Yamaura A.
        • Nakamura T.
        • Makino H.
        • Hagihara Y.
        Cerebral complication of antifibrinolytic therapy in the treatment of ruptured intracranial aneurysm. Animal experiment and a review of literature.
        Eur Neurol. 1980; 19: 77-84
        View in Article
        • Godec S.
        • Gradisek M.J.
        • Mirkovic T.
        • Gradisek P.
        Ventriculolumbar perfusion and inhalational anesthesia with sevoflurane in an accidental intrathecal injection of tranexamic acid: unreported treatment options.
        Reg Anesth Pain Med. 2022; 47: 65-68
        View in Article
        • Patel S.
        • Robertson B.
        • McConachie I.
        Catastrophic drug errors involving tranexamic acid administered during spinal anaesthesia.
        Anaesthesia. 2019; 74: 904-914
        View in Article
        • Bishop D.G.
        • Lundgren A.C.
        • Moran N.F.
        • Popov I.
        • Moodley J.
        Intrathecal tranexamic acid during spinal anaesthesia for caesarean delivery: a lethal drug error.
        S Afr Med J. 2019; 109: 841-844
        View in Article
        • Sentilhes L.
        • Sénat M.V.
        • Le Lous M.
        • Winer N.
        • Rozenberg P.
        • Kayem G.
        • et al.
        Tranexamic acid for the prevention of blood loss after cesarean delivery.
        N Engl J Med. 2021; 384: 1623-1634
        View in Article

      9. World Health Organization. Risk of medication errors with tranexamic acid injection resulting in inadvertent intrathecal injection. 2022. Available at: https://www.who.int/news/item/16-03-2022-risk-of-medication-errors-with-tranexamic-acid-injection-resulting-in-inadvertent-intrathecal-injection. Accessed March 28, 2022.

        View in Article

      10. US Food and Drug Administration. FDA alerts healthcare professionals about the risk of medication errors with tranexamic acid injection resulting in inadvertent intrathecal (spinal) injection. 2020. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-healthcare-professionals-about-risk-medication-errors-tranexamic-acid-injection-resulting. Accessed March 28, 2022.

        View in Article

      11. Fukushima A. Addressing look-alike, sound-alike medicines: role of regulatory agencies. World Health Organization. 2021. Available at: https://cdn.who.int/media/docs/default-source/patient-safety/gpsn-webinar/2021-medication-safety/gpsn_webinar_ayako-fukushima_09april2021.pdf?sfvrsn=7e36b8f1_5. Accessed March 28, 2022.

        View in Article

      12. Pharmaceutical Services Division Ministry of Health Malaysia. Guide on handling look alike, sound alike medications. 20Available at: https://www.pharmacy.gov.my/v2/sites/default/files/document-upload/guide-handling-lasa.pdf. Accessed March 28, 2022.

        View in Article

      Article Info

      Publication History

      Published online: October 21, 2022

      Identification

      DOI: https://doi.org/10.1016/j.ejogrb.2022.09.016

      Copyright

      © 2022 The Author(s). Published by Elsevier Inc /Elsevier B.V./ Wiley on behalf of The International Federation of Gynecology and Obstetrics (FIGO) / John Wiley & Son Ltd. This article is published under the Creative Commons CC-BY license.

      User License

      Creative Commons Attribution (CC BY 4.0) |
      How you can reuse Information Icon
      Creative Commons Attribution (CC BY 4.0)

      Permitted

      • Read, print & download
      • Redistribute or republish the final article
      • Text & data mine
      • Translate the article
      • Reuse portions or extracts from the article in other works
      • Sell or re-use for commercial purposes

      Elsevier's open access license policy

      ScienceDirect

      Access this article on ScienceDirect
      We use cookies to help provide and enhance our service and tailor content. To update your cookie settings, please visit the for this site.
      Copyright © 2022 Elsevier Inc. except certain content provided by third parties. The content on this site is intended for healthcare professionals.


      RELX