PFD report

Mohammed Shabol AHMED · Prevention of Future Deaths report

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Issued 19 Mar 2019•Suffolk

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
2

Raised in this report

Recipients
2

Named on the report

Responses found
1

Of 2 recipients

Stated actions
0

Described in responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

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Report evidence summary

Concerns raised2

  1. Failure to establish whether information about olanzapine-associated drug reaction with eosinophilia and systemic symptoms is known to clinicians nationally
    Part of recurring concern: Unreliable dissemination of safety-critical clinical guidance and learning
  2. Risk of adverse allergic reactions and drug reaction with eosinophilia and systemic symptoms from combined Spice use and olanzapine exposure
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.1

  1. Position

    Current olanzapine warnings adequately address the identified risks, so no further regulatory action is considered necessary at this time.

    Stated by Department of Health and Social CareExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

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

Failure to establish whether information about olanzapine-associated drug reaction with eosinophilia and systemic symptoms is known to clinicians nationally

Wider context from the report

“(1) The expert evidence of ████████ (Emeritus of Forensic Medicine) gave evidence that the use of Spice can prime a person for an allergic reaction. In the case of Mr Ahmed Olanzapine and Spice combined to cause an adverse allergic reaction. He had been prescribed Olanzapine throughout his imprisonment in the knowledge of Spice use. (2) Healthcare records demonstrated that his eosinophilia count was recorded as reduced following a change in medication from Olanzapine to Risperidone. (3) The expert evidence was that it was a very rare side effect but one which the U.S. Food and Drug Administration has warned that drug reaction with eosinophilia and systemic symptoms has been reported with olanzapine exposure. (4) The jury was not able to find that the death was caused or contributed to by the use of Spice. It remains unclear whether the expert opinion is one which is or should be made known to clinicians nationally. ”

Is this part of a recurring concern?

Yes — Unreliable dissemination of safety-critical clinical guidance and learning.

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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

Risk of adverse allergic reactions and drug reaction with eosinophilia and systemic symptoms from combined Spice use and olanzapine exposure

Wider context from the report

“(1) The expert evidence of ████████ (Emeritus of Forensic Medicine) gave evidence that the use of Spice can prime a person for an allergic reaction. In the case of Mr Ahmed Olanzapine and Spice combined to cause an adverse allergic reaction. He had been prescribed Olanzapine throughout his imprisonment in the knowledge of Spice use. (2) Healthcare records demonstrated that his eosinophilia count was recorded as reduced following a change in medication from Olanzapine to Risperidone. (3) The expert evidence was that it was a very rare side effect but one which the U.S. Food and Drug Administration has warned that drug reaction with eosinophilia and systemic symptoms has been reported with olanzapine exposure. (4) The jury was not able to find that the death was caused or contributed to by the use of Spice. It remains unclear whether the expert opinion is one which is or should be made known to clinicians nationally. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

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

Current olanzapine warnings adequately address the identified risks, so no further regulatory action is considered necessary at this time.

Verbatim wording from the response

“I am advised by the MHRA that it considers the current warnings on the Summary of Product Characteristics (SPC) for olanzapine about adverse drug reactions of eosinophilia, and of drug reaction with eosinophilia and systemic symptoms with olanzapine appropriately address the nature of these risks, and given the absence of similar reported cases, does not intend to take further regulatory action at this time.”

Source location

2019-0093-Response-by-Department-of-Health
Page 1 · response
Published 14 June 2019

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

Official responses located
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Data last updated 7 September 2026