PFD report

Michael John Spencer · Prevention of Future Deaths report

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Issued 5 Feb 2018•South Yorkshire (Western)

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
1

Named on the report

Responses found
0

Of 1 recipient

Stated actions
0

Described in responses

Recipients and published responses

Source document

Full report text

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Concerns and recipient responses

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Concerns raised1

  1. Unavailability in the UK of Andexanet alfa for severe bleeding during treatment with Factor Xa inhibitor anticoagulants
    Part of recurring concern: Inadequate reversal treatment for Factor Xa inhibitor bleeding
Responses linked to these concerns

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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

Unavailability in the UK of Andexanet alfa for severe bleeding during treatment with Factor Xa inhibitor anticoagulants

Wider context from the report

“Rivaroxaban is one of 4 Factor Xe inhibitor 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 the 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. ”

Is this part of a recurring concern?

Yes — Inadequate reversal treatment for Factor Xa inhibitor bleeding.

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

Data last updated 7 September 2026