Michael Spencer
PFD Report
Historic (No Identified Response)
Ref: 2018-0032
Coroner's Concerns (AI summary)
A specific drug (Andexanet alfa) to reverse potentially fatal bleeding caused by Factor Xa inhibitor anticoagulants is not available in the UK, even for compassionate use.
View full coroner's concerns
Rivaroxaban is one of 4 Factor Xe inhibiter anticoagulants currently available. Potentially fatal bleeding can take place following overdose of these drugs or following even relatively injury when patients are taking them. A drug specifically designed to reverse the anti-coagulant effect of the Factor Xa antagonist, Andexanet alfa, is available in some countries which can be used in such circumstances to reverse the anticoagulant effect of these drugs. Evidence was given at the inquest to the effect It is not yet available in the UK, even for compassionate use, and that its availability could be lifesaving when severe bleeding occurs during treatment with Factor Xa inhibitor anti-coagulant drugs. For the avoidance of doubt, this evidence was given in the course of a general explanation of the action of Rivaroxaban and the management of pathological bleeding during its use. It was made clear that the ready availability of Andexanet alfa would not have changed the outcome in Mr Spencer’s case. The concern expressed was in relation to the current non-availability of this specific reversal agent in the face of the increasing clinical use of Factor Xa inhibitor anticoagulants.
Sent To
- Medicines and Healthcare products Regulatory Agency
Response Status
Linked responses
0 of 1
56-Day Deadline
3 Aug 2018
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 29th August 2017 I commenced an investigation into the death of Michael John Spencer. The investigation concluded at the end of the inquest on 31st January 2018. The conclusion of the inquest was 1a) Intracerebral haemorrhage; 1b) Rivaroaxban anticoagulant treatment; 2) Ischaemic stroke (treated), Hypertension (treated).
Circumstances of the Death
Michael Spencer had a fatal midbrain haemorrhage when being treated with Rivaroxaban as part of a clinical trial.
Copies Sent To
Chief Executive, Sheffield Teaching Hospitals Trust NHS Foundation Trust
Sheffield Teaching Hospitals Trust NHS Foundation Trust
, Consultant Neurologist, Royal Hallamshire Hospital, Sheffield
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.