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)
Clive Hyman
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.
Coroner's concerns
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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
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)
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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,
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)
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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.
Report sections
Investigation and inquest
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
Similar PFD reports
Related inquiry recommendations
Report details
- Reference
- 2026-0034
- Date of report
- 22 January 2026
- Coroner
- Sarah Bourke
- Coroner area
- Inner North London
Responses identified
Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 19 Mar 2026 (estimated).
Sent to
- Association of the British Pharmaceutical Industry
- Medicines and Healthcare Products Regulatory Agency
- Medicines UK