Recurring concern

Inadequate reversal treatment for Factor Xa inhibitor bleeding

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First reported 5 Feb 2018•Latest report 30 Dec 2019

Definition

What this concern includes

Includes failures or hazards in the availability, licensing, commissioning, guidance or delivery of reversal treatment for serious bleeding associated with Factor Xa inhibitor anticoagulants, including edoxaban and rivaroxaban, where the lack of an effective reversal option or access arrangement can delay or limit urgent treatment.

Not included

  • Excludes general anticoagulant prescribing, monitoring, thromboprophylaxis or bleeding-risk assessment failures where reversal treatment is not the deficient control.
  • Excludes treatment of bleeding unrelated to Factor Xa inhibitor anticoagulants.
  • Excludes absence or limited availability of antidotes for other medicines, poisons or overdoses unless the assertion explicitly concerns reversal of Factor Xa inhibitor anticoagulation.
  • Excludes cases where appropriate reversal treatment was available and the deficiency was solely a later clinical decision or treatment error.
Reports
2

Distinct published reports

Individual concerns
2

A report can raise multiple concerns

Date range
2018–2019

First to latest report issue date

Stated actions
0

Described in published responses

Reports over time

Reports over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Most frequent recipients

Reports about this concern sent to each recipient.

Department of Health and Social Care1
Greater Manchester Health and Social Care Partnership1
Greater Manchester Mental Health NHS Foundation Trust1
Medicines and Healthcare products Regulatory Agency1
National Institute for Health and Care Excellence1

Concerns and responses across reports

Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.

  1. Manchester South

    AI-generated summary

    Maureen Waterfall · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Maureen Waterfall fell at home on 12 July 2019 while taking the anticoagulant Edoxaban and sustained a head injury that led to a subdural haematoma. She died at Willow Wood Hospice on 26 July 2019. Concerns included the lack of a licensed specific antidote for Edoxaban, uncertainty about treatment effectiveness and timing, the absence of national guidance, and the storage of antidote supplies away from the resuscitation unit.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Absence of a currently licensed antidote for Edoxaban

    Wider context from the report

    “1. I heard evidence from ████████ Clinical Director of Neurosciences at Salford Royal Hospital. He told me that Edoxaban was one of the new anticoagulant drugs, but of those with which he is familiar, it is differentiated by the fact that there is no currently licensed antidote. He is aware of clinical trials being undertaken of such an antidote. ”

    Source location

    Maureen Waterfall · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

  2. South Yorkshire (Western)

    AI-generated summary

    Michael John Spencer · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Michael Spencer died from a fatal midbrain haemorrhage while being treated with Rivaroxaban as part of a clinical trial. The concern was that Andexanet alfa, a specific reversal agent for Factor Xa inhibitor anticoagulants, was not available in the UK, although the evidence stated that its availability would not have changed the outcome in Mr Spencer’s case.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Unavailability in the UK of Andexanet alfa for severe bleeding during treatment with Factor Xa inhibitor anticoagulants

    Wider context from the report

    “Rivaroxaban is one of 4 Factor Xe inhibitor anticoagulants currently available. Potentially fatal bleeding can take place following overdose of these drugs or following even relatively injury when patients are taking them. A drug specifically designed to reverse the anti-coagulant effect of the Factor Xa antagonist, Andexanet alfa, is available in some countries which can be used in such circumstances to reverse the anticoagulant effect of the drugs. Evidence was given at the inquest to the effect It is not yet available in the UK, even for compassionate use, and that its availability could be lifesaving when severe bleeding occurs during treatment with Factor Xa inhibitor anti-coagulant drugs. For the avoidance of doubt, this evidence was given in the course of a general explanation of the action of Rivaroxaban and the management of pathological bleeding during its use. It was made clear that the ready availability of Andexanet alfa would not have changed the outcome in Mr Spencer’s case. The concern expressed was in relation to the current non-availability of this specific reversal agent in the face of the increasing clinical use of Factor Xa inhibitor anticoagulants. ”

    Source location

    Michael John Spencer · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report
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Data last updated 7 September 2026