PFD report

Clive Mark Hyman · Prevention of Future Deaths report

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Issued 22 Jan 2026•Inner North London

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

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Concerns
1

Raised in this report

Recipients
3

Named on the report

Responses found
3

Of 3 recipients

Stated actions
4

Described in responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

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Report evidence summary

Concerns raised1

  1. Lack of patient information on actions after head trauma during apixaban treatment
    Part of recurring concern: Inadequate patient bleeding-risk information for direct oral anticoagulant treatment
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.4

  1. Action

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

    Stated by Association of the British Pharmaceutical IndustryStated completedThe respondent said that this action was complete when they made their response on 26 January 2026.
  2. Action

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

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 26 January 2026.
  3. Action

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

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 26 January 2026.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.3

  1. Position

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

    Stated by Association of the British Pharmaceutical IndustryRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

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. ”

Is this part of a recurring concern?

Yes — Inadequate patient bleeding-risk information for direct oral anticoagulant treatment.

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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

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

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

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

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

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

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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

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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Official responses located
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Data last updated 7 September 2026