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Tranexamic acid at cesarean delivery: drug-error deaths

Published:October 21, 2022DOI:https://doi.org/10.1016/j.ejogrb.2022.09.016

      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)
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      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.

        • 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
      2. 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.

        • 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
        • 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
        • Patel S.
        • Robertson B.
        • McConachie I.
        Catastrophic drug errors involving tranexamic acid administered during spinal anaesthesia.
        Anaesthesia. 2019; 74: 904-914
        • 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
        • 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
      3. 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.

      4. 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.

      5. 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.

      6. 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.