Clive Hyman
PFD Report
All Responded
Ref: 2026-0034
All 3 responses received
· Deadline: 19 Mar 2026
Coroner's Concerns (AI summary)
Patient information leaflets for Apixaban do not adequately advise on actions following head trauma, risking delayed medical intervention for intracranial bleeds in patients taking anticoagulants.
View full coroner's concerns
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.
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.
Responses
Action Taken
The ABPI, as a trade association without regulatory authority, has made the originator company, Bristol Myers Squibb (BMS), aware of the coroner's report and concerns regarding apixaban patient safety information and labelling. (AI summary)
The ABPI, as a trade association without regulatory authority, has made the originator company, Bristol Myers Squibb (BMS), aware of the coroner's report and concerns regarding apixaban patient safety information and labelling. (AI summary)
View full response
Dear Ms Bourke, Thank you for your Regulation 28 report dated 22 January 2026 concerning the death of Mr Clive Mark Hyman. Please accept our sincere condolences to Mr Hyman’s family for their tragic loss. We appreciate being notified and for the thoroughness of your investigation. 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). 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. 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.
Noted
MedicinesUK states its member companies will comply with any future changes to product information regarding anticoagulants and head trauma warnings, should such changes be required by the MHRA. (AI summary)
MedicinesUK states its member companies will comply with any future changes to product information regarding anticoagulants and head trauma warnings, should such changes be required by the MHRA. (AI summary)
View full response
Dear Ms Bourke,
Thank you for your letter of 26th January detailing matters of concern identified following the inquest into the death of Clive Mark Hyman.
You specifically wrote regarding a Regulation 28 report to prevent future deaths. We noted that your letter was also sent to the Chair of the MHRA, the medicines regulator.
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.
Thank you for contacting us, and we pass on our condolences to the family and friends of Mr Hyman.
Best regards,
Thank you for your letter of 26th January detailing matters of concern identified following the inquest into the death of Clive Mark Hyman.
You specifically wrote regarding a Regulation 28 report to prevent future deaths. We noted that your letter was also sent to the Chair of the MHRA, the medicines regulator.
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.
Thank you for contacting us, and we pass on our condolences to the family and friends of Mr Hyman.
Best regards,
Action Taken
The MHRA has completed a preliminary assessment and initiated a full review across all Direct Oral Anticoagulants (DOACs) and warfarin regarding patient information leaflet warnings for head trauma, with plans to seek expert advice on potential updates. (AI summary)
The MHRA has completed a preliminary assessment and initiated a full review across all Direct Oral Anticoagulants (DOACs) and warfarin regarding patient information leaflet warnings for head trauma, with plans to seek expert advice on potential updates. (AI summary)
View full response
Dear Sarah Bourke,
Coroners and Justice Act 2009 – Regulation 28 Report following the Inquest into the death of Clive Hyman.
Thank you for your letter dated 22 January 2026, received on 23 January, enclosing your Report under Regulation 28 following the Inquest into the death of Clive Hyman. We would like to offer our sincere condolences to his family.
Your report raised concerns with regard to the adequacy of warnings in the patient information leaflet in the event a patient suffers a head trauma while taking anticoagulant therapy.
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.
As a result the assessment and any updates to the Product Information, including the Patient Information Leaflet will require some time to complete.
This interim letter informs you of our course of action and we will update you of any actions following the completion of the review. Please do not hesitate to contact us if you have any further questions.
Coroners and Justice Act 2009 – Regulation 28 Report following the Inquest into the death of Clive Hyman.
Thank you for your letter dated 22 January 2026, received on 23 January, enclosing your Report under Regulation 28 following the Inquest into the death of Clive Hyman. We would like to offer our sincere condolences to his family.
Your report raised concerns with regard to the adequacy of warnings in the patient information leaflet in the event a patient suffers a head trauma while taking anticoagulant therapy.
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.
As a result the assessment and any updates to the Product Information, including the Patient Information Leaflet will require some time to complete.
This interim letter informs you of our course of action and we will update you of any actions following the completion of the review. Please do not hesitate to contact us if you have any further questions.
Sent To
- Medicines and Healthcare Products Regulatory Agency
Response Status
Linked responses
3 of 3
56-Day Deadline
19 Mar 2026
All responses received
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Report Sections
Investigation and Inquest
On 21 August 2025, Senior Coroner Hassell commenced an investigation into the death of Clive Mark Hyman aged 64 years. The investigation concluded at the end of the inquest on 13 January 2026.
The conclusion of the inquest was that “Mr Hyman presented with severe brain injuries a few days after falling and hitting his head. He died in hospital on 10 August 2025”.
I returned a conclusion that death was due to accident.
The medical cause of death was: 1a traumatic subdural haemorrhage (operated); 2 atrial fibrillation (treated with apixaban), coronary artery bypass graft.
The conclusion of the inquest was that “Mr Hyman presented with severe brain injuries a few days after falling and hitting his head. He died in hospital on 10 August 2025”.
I returned a conclusion that death was due to accident.
The medical cause of death was: 1a traumatic subdural haemorrhage (operated); 2 atrial fibrillation (treated with apixaban), coronary artery bypass graft.
Circumstances of the Death
Mr Hyman was 64 years old, active and in good general health. He was prescribed apixaban following treatment for atrial fibrillation and a coronary artery bypass graft. On 1 August 2025, Mr Hyman tripped on the stairs whilst making a telephone call. He informed his colleague that he had hit his head but was feeling “fine”. He subsequently told his wife about falling on some marble steps. Mr Hyman did not seek medical advice following the fall. Neither he nor his wife was aware that taking apixaban presented a risk in relation to head trauma. Mr Hyman presented normally until 1 pm on 5 August 2025 when he developed a sudden, severe headache. His blood pressure was also extremely high. His wife called the ambulance service and was told that it was a “non-emergency”. Mr Hyman took some paracetamol and went to bed. Around 3.45 pm, his wife heard him choking. She saw that he had vomited and was unresponsive. A further call was made to the ambulance service, paramedics attended and conveyed Mr Hyman to his local emergency department. A CT scan revealed that Mr Hyman had a left-sided subdural haemorrhage. He was given prothrombin and tranexamic acid to help reverse apixaban and given hypertonic saline prior to being transferred to the regional trauma centre. Mr Hyman underwent an emergency left-sided decompressive craniectomy on arrival which was uneventful. He was transferred to the adult critical care unit. A CT scan taken on 6 August showed that Mr Hyman had bleeding within the pons and changes consistent with an ischaemic stroke. Sedation was withdrawn on 8 August, but Mr Hyman continued to have a profoundly decreased level of consciousness. Further imaging on 9 August established that he had had an extensive stroke affecting the entirety of the left hemisphere of the brain. Neurosurgeons advised that the prospects of any meaningful recovery were poor. Mr Hyman died in the early hours of 10 August.
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.