Association of the British Pharmaceutical Industry

Private and voluntary organisations · Trade association

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First report 22 Jan 2026•Latest report 22 Jan 2026

Reports, concerns and published responses

Reports over time

Reports naming this recipient by issue year.

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

Reports
1

Naming this recipient

Published responses
100%

Found for named reports

Concerns addressed
1

Across all linked responses

Stated actions
1

Described in responses

Concerns and recipient responses

Statements from Association of the British Pharmaceutical Industry linked to the concerns in each report. Select any concern, action or position to view the source wording.

  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. The report was sent to Association of the British Pharmaceutical Industry; that does 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. ”
    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

    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

    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

    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

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

Data last updated 7 September 2026