Recurring concern

Inadequate patient bleeding-risk information for direct oral anticoagulant treatment

First to latest report 16 Jun 2016 — 22 Jan 2026

Reports that mention this concern
3
Times this concern has been raised
3
Stated actions linked to this concern
12

What this concern includes

Includes deficiencies in patient-facing information, counselling, warnings or discharge communication specifically dedicated to safe apixaban treatment, including advice about bleeding, trauma and when to seek urgent medical help.

What is not included
  • Excludes anticoagulation management protocols or clinical treatment decisions that are not patient-information controls.
  • Excludes generic deficiencies in patient information governance unless explicitly tied to apixaban safety information.
  • Excludes information deficiencies concerning other medicines or unrelated hazards.
  • Excludes failures of hospital referral or trauma assessment unless the reported failure is specifically the apixaban patient-information control.

Reports and published responses 3 reports

See individual reports that have raised this concern, and the actions taken in response

  1. Inner North London

    AI-generated summary

    Clive Mark Hyman · 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

    Clive Mark Hyman, who was taking apixaban, fell and hit his head on 1 August 2025 but did not seek medical advice because he felt well. He later developed a sudden severe headache, became unresponsive, and was found to have a subdural haemorrhage and extensive brain injury; he died in hospital on 10 August 2025. The concerns relate to guidance for people taking apixaban after head trauma, including the absence of clear advice in reviewed patient leaflets to seek medical attention after such an injury.

    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

    Lack of patient information on actions after head trauma during apixaban treatment

    Wider context from the report

    “1) NICE guidelines NG232 on the Assessment and Early Management of Head Injury state at paragraph 1.2.1 “Public health literature and other non-medical sources of advice ... should encourage people who have any concerns after a head injury ... to seek immediate medical advice. Paragraphs 1.2.3 and 1.2.4 of the guidance state that remote advice services and community health services “should refer people who have sustained a head injury to a hospital emergency department ... if there are any of these risk factors ... current anticoagulant or antiplatelet (except aspirin monotherapy) treatment” 2) Having reviewed several patient information leaflets issued with apixaban, it is evident that patients are routinely advised not to take the drug if they are “bleeding excessively”. In addition, they are advised to seek medical advice if they are at “increased risk of bleeding”. None of the patient information leaflets that I reviewed expressly addressed the steps to be taken by a patient if they sustain trauma to the head. 3) Patients who have experienced head trauma may not realise that they have sustained an intracranial bleed. As head injuries can be asymptomatic for some time following trauma, apixaban users may continue taking the medication and avoid seeking medical advice because they feel well. As a result of taking apixaban, bleeding may continue. By the time symptoms of a brain injury emerge (e.g. a sudden, severe headache) the patient may be critically ill and have a reduced potential for recovery. ”

    Source location

    Clive Mark Hyman · Prevention of Future Deaths report
    Page 3 · concerns

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    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Notify Bristol Myers Squibb of the coroner’s report and concerns about apixaban product information and patient materials.

    Verbatim wording from the response

    “We have however made the originator company, Bristol Myers Squibb (BMS), aware of your report and the coroner’s concerns so they can consider any appropriate action regarding product information and patient materials.”

    Source location

    Response from abpi
    Page 1 · response
    Published 26 January 2026

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    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Complete a preliminary assessment of head-trauma warnings for patients taking anticoagulants and discuss the issue at an internal multidisciplinary review meeting.

    Verbatim wording from the response

    “To date we have completed a preliminary assessment of the issue, which was also discussed at an internal multidisciplinary Review Meeting. We can confirm that a full review, across all Direct Oral Anticoagulants (DOACs; including apixaban) and warfarin, is now underway. Once finalised we will seek expert advice regarding any potential updates to product information.”

    Source location

    Response from Medicines & Healthcare products Regulatory Agency
    Page 1 · response
    Published 26 January 2026

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    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Conduct a full review of patient information for all direct oral anticoagulants, including apixaban, and warfarin.

    Verbatim wording from the response

    “To date we have completed a preliminary assessment of the issue, which was also discussed at an internal multidisciplinary Review Meeting. We can confirm that a full review, across all Direct Oral Anticoagulants (DOACs; including apixaban) and warfarin, is now underway. Once finalised we will seek expert advice regarding any potential updates to product information.”

    Source location

    Response from Medicines & Healthcare products Regulatory Agency
    Page 1 · response
    Published 26 January 2026

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    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Seek expert advice on potential updates to anticoagulant product information after finalising the full review.

    Verbatim wording from the response

    “To date we have completed a preliminary assessment of the issue, which was also discussed at an internal multidisciplinary Review Meeting. We can confirm that a full review, across all Direct Oral Anticoagulants (DOACs; including apixaban) and warfarin, is now underway. Once finalised we will seek expert advice regarding any potential updates to product information.”

    Source location

    Response from Medicines & Healthcare products Regulatory Agency
    Page 1 · response
    Published 26 January 2026

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    Source evidence

    How this respondent position was interpreted

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

    PFD Monitor interpretation

    Changing individual medicines’ product leaflets or labelling is outside the organisation’s regulatory authority.

    Verbatim wording from the response

    “Because the coroner’s matters principally concern (a) clinical guidance for head injury and (b) patient-facing safety information and labelling for apixaban, and because the MHRA is the statutory regulator for licensing and labelling, ABPI itself has no regulatory levers to change product leaflets or labelling for individual medicines.”

    Source location

    Response from abpi
    Page 1 · response
    Published 26 January 2026

    Open published response

    Source evidence

    How this respondent position was interpreted

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

    PFD Monitor interpretation

    The MHRA and marketing authorisation holders are responsible for decisions on statutory labelling, patient information leaflets and licence changes.

    Verbatim wording from the response

    “The Association of the British Pharmaceutical Industry (ABPI) is a trade association representing the research-based biopharmaceutical industry in the UK. The ABPI is not a marketing authorisation holder for medicinal products, and it does not have statutory licensing or labelling authority for medicines. This regulatory responsibility sits with the Medicines and Healthcare products Regulatory Agency (MHRA), whom I note you have also sent this Regulation 28 report to. Decisions on statutory labelling, approved patient information leaflets (PILs) and licence changes are for the MHRA and the marketing authorisation holder(s).”

    Source location

    Response from abpi
    Page 1 · response
    Published 26 January 2026

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    Source evidence

    How this respondent position was interpreted

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

    PFD Monitor interpretation

    Existing MHRA pharmacovigilance requirements are considered sufficient because member companies must comply with any regulator-required medicine information changes.

    Verbatim wording from the response

    “Member companies of Medicines UK that are marketing authorisation holders for medicines containing apixaban are legally required to comply with MHRA’s pharmacovigilance requirements, which may include changes to product information. Therefore, you can be assured that our members will comply with any future changes required by the regulator.”

    Source location

    Response from MedicinesUK
    Page 1 · response
    Published 26 January 2026

    Open published response

  2. North East Kent

    AI-generated summary

    KEITH RUPERT DIMOND · 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

    Keith Dimond died on 24 November 2021 at Queen Elizabeth Queen Mother Hospital following a catastrophic bleed from a ruptured iliac artery aneurysm, with anticoagulation contributing to the excessive bleeding. Concerns included communication failures about the known iliac artery aneurysm, lack of information about bleeding risks when anticoagulation was prescribed, delayed escalation when he deteriorated, and haematology advice on anticoagulation not being followed on two occasions.

    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

    Failure to provide written and family-shared bleeding-risk advice for direct oral anticoagulant medication

    Wider context from the report

    “(2) The patient was discharged on 19 October 2022 with a new diagnosis of Atrial Fibrillation and prescription of Direct Oral Anticoagulant Apixaban was prescribed. The patient was not given any written advice on the risks as to bleeding on this medication and the risks were not shared with family on discharge. This led to advice being sought from 111 and a long delay before 999 was called when the patient deteriorated on 22 October 2022. ”

    Source location

    KEITH RUPERT DIMOND · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Create and implement a generic anticoagulant discharge leaflet covering bleeding risks, warning signs and when to seek medical attention.

    Verbatim wording from the response

    “I can confirm that the Trust is in the process of creating and implementing a generic anticoagulant patient leaflet, which will be provided to patients upon discharge from hospital. The leaflet will cover information around risks of bleeding, signs and symptoms to look for in terms of bleeding and when to seek medical attention. The leaflet is due to be finalised by the end of March 2023.”

    Source location

    Response from East Kent Hospitals University
    Page 2 · response
    Published 28 October 2022

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  3. West Sussex

    AI-generated summary

    Valerie Margaret Ellis · 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

    Valerie Margaret Ellis, an 83-year-old woman, died at home on 6 September 2015 after a massive gastrointestinal bleed associated with Apixaban. The report identified concerns about inadequate counselling on the medication, communication and call-handling problems in NHS 111, premature closure of an IC24 case, and aspects of ambulance triage.

    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

    Lack of a policy for discharge counselling and warning cards for Apixaban

    Wider context from the report

    “1) On discharge from the hospital the use of Apixaban in an elderly confused patient being cared for by a carer with hearing loss should have merited careful counselling by the clinicians and the use of a warning card. Whilst the hospital is taking steps to assess this area, my understanding is that no policy has been adopted and I feel it should be made a matter of urgency. ”

    Source location

    Valerie Margaret Ellis · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Launch and maintain a NOAC alert card for patients prescribed apixaban and other new oral anticoagulants.

    Verbatim wording from the response

    “The Trust has welcomed the opportunity to build upon the work already in place to ensure that patients prescribed Apixaban receive the very best information about the potential side-effects. Despite the absence of national guidance, the Trust has continued to strive to develop a system to ensure that both counselling and a warning card provide patients and their carers with a firm understanding of the risks, as well as the benefits, of this and other new oral anticoagulants (NOAC).”

    Source location

    2016-0252-Response-by-Western-Sussex-Hospital-NHS-Trust
    Page 1 · response
    Published 16 June 2016

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    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Introduce a pharmacy standard operating procedure supporting NOAC alert-card distribution.

    Verbatim wording from the response

    “As you will be aware, the Trust launched the NOAC alert card in October 2015 and introduced a Standard Operating Procedure to enable pharmacy staff to be fully appraised of the new system and to support the distribution of the warning card. In addition, daily reminders generated by the electronic prescribing software ensure that new patients are identified. It is hoped to strengthen the system still further by placing a further NOAC card in the medication bag given to patients on discharge and to ensure that all discussions with relatives and carers regarding the new drug are documented.”

    Source location

    2016-0252-Response-by-Western-Sussex-Hospital-NHS-Trust
    Page 1 · response
    Published 16 June 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Adopt the Patient First methodology to review the entire NOAC care process.

    Verbatim wording from the response

    “The Patient First initiative sits at the very heart of the Western Sussex NHS Foundation Trust’s vision of continuous improvement and provides a framework for reviewing each stage of a patient care process. While the above actions seek to address the former inadequacies of the counselling process, it is intended to adopt this methodology to review the entire NOAC process. The standards are being captured in the revised policy for prescribing and administration of anti-coagulants. The policy includes that newly initiated patients are consented by the medical staff as treatment is initiated and receive written information and counselling during the stay and at discharge from nursing and pharmacy staff.”

    Source location

    2016-0252-Response-by-Western-Sussex-Hospital-NHS-Trust
    Page 2 · response
    Published 16 June 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Revise the anticoagulant prescribing and administration policy to capture NOAC counselling, consent and written-information standards.

    Verbatim wording from the response

    “The Patient First initiative sits at the very heart of the Western Sussex NHS Foundation Trust’s vision of continuous improvement and provides a framework for reviewing each stage of a patient care process. While the above actions seek to address the former inadequacies of the counselling process, it is intended to adopt this methodology to review the entire NOAC process. The standards are being captured in the revised policy for prescribing and administration of anti-coagulants. The policy includes that newly initiated patients are consented by the medical staff as treatment is initiated and receive written information and counselling during the stay and at discharge from nursing and pharmacy staff.”

    Source location

    2016-0252-Response-by-Western-Sussex-Hospital-NHS-Trust
    Page 2 · response
    Published 16 June 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Establish a multidisciplinary group to design and introduce mechanisms embedding the revised NOAC policy in practice.

    Verbatim wording from the response

    “Concurrently plans are underway for the establishment of a multi-disciplinary group to design and introduce mechanisms to ensure the policy is embedded in practice including actions to formalize electronic recording of counselling discussions, an initiation checklist for use by prescribers and patient leaflets to support the NOAC card. Mrs Ellis’s family has been invited to be part of this group and we very much hope that, in time, they will wish to be involved. The Trust’s incident reporting system will provide an invaluable tool to assist future audits to measure the effectiveness of these new initiatives.”

    Source location

    2016-0252-Response-by-Western-Sussex-Hospital-NHS-Trust
    Page 2 · response
    Published 16 June 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Formalize electronic recording of NOAC counselling discussions.

    Verbatim wording from the response

    “Concurrently plans are underway for the establishment of a multi-disciplinary group to design and introduce mechanisms to ensure the policy is embedded in practice including actions to formalize electronic recording of counselling discussions, an initiation checklist for use by prescribers and patient leaflets to support the NOAC card. Mrs Ellis’s family has been invited to be part of this group and we very much hope that, in time, they will wish to be involved. The Trust’s incident reporting system will provide an invaluable tool to assist future audits to measure the effectiveness of these new initiatives.”

    Source location

    2016-0252-Response-by-Western-Sussex-Hospital-NHS-Trust
    Page 2 · response
    Published 16 June 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Introduce patient leaflets supporting the NOAC alert card.

    Verbatim wording from the response

    “Concurrently plans are underway for the establishment of a multi-disciplinary group to design and introduce mechanisms to ensure the policy is embedded in practice including actions to formalize electronic recording of counselling discussions, an initiation checklist for use by prescribers and patient leaflets to support the NOAC card. Mrs Ellis’s family has been invited to be part of this group and we very much hope that, in time, they will wish to be involved. The Trust’s incident reporting system will provide an invaluable tool to assist future audits to measure the effectiveness of these new initiatives.”

    Source location

    2016-0252-Response-by-Western-Sussex-Hospital-NHS-Trust
    Page 2 · response
    Published 16 June 2016

    Open published response

Actions and positions describe what organisations say in published responses. Implementation is not independently verified.

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Data last updated 7 September 2026