Recipient

Viatris UK Healthcare LimitedIncludes reports addressed to a minister or senior office-holder acting for this organisation.

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First report 18 Jul 2024•Latest report 18 Jul 2024

Recipient record

Reports, concerns and published responses

Private and voluntary organisations · Private limited company. This page brings together reports naming this recipient and response statements clearly connected to concerns raised in those reports.

Reports
1

Naming this recipient

Published responses
100%

Found for named reports

Concerns addressed
1

Across all linked responses

Stated actions
3

Described in responses

Reports over time

Reports over time

Reports naming this recipient by issue year.

Evidence profile

Report topics

Share of this recipient’s reports compared with all other recipients.

100%published responses found
3stated actions described

Topic comparisons are not available in the current evidence snapshot.

Concerns and recipient responses

Statements from Viatris UK Healthcare Limited linked to the concerns in each report. Select any concern, action or position to view the source wording.

  1. Addressed to: ████████ Chief Executive Officer, Vitaris UK Healthcare Ltd.

    Manchester South

    AI-generated summary

    Sasha Drysdale · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Sasha Drysdale died on 28 March 2023 in hospital as a consequence of acute myeloid leukaemia transformed from myelodysplastic syndrome. She had previously been prescribed clozapine for treatment-resistant schizoaffective disorder and was detained under section 3 of the Mental Health Act 1983 at the time of her death. The concern raised was that further research is needed to establish whether clozapine materially increases the risk of certain blood cancers.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Viatris UK Healthcare Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Potential increased risk of certain blood cancers among patients taking Clozapine

    Wider context from the report

    “The court heard evidence as to a small number of studies conducted internationally which, whilst having small sample sizes, could be read as suggesting an increased incidence of certain forms of blood cancer amongst those taking Clozapine. I am concerned that further research is needed to either refute or confirm whether or not taking Clozapine materially increases the risk of a patient developing certain blood cancers. ”
    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Complete a signal-validation and assessment exercise on potential associations between clozapine and haematological malignancies, including literature and safety-data analysis.

    Verbatim wording from the response

    “3.9 As part of Viatris’ pharmacovigilance activities for the Product, if any new safety information (showing potential correlation between the Product and a potential safety issue) is identified from any of the activities listed in paragraph 3.3, it triggers a process whereby Viatris will undertake a signal validation and assessment exercise in accordance with GVP module IX. This exercise involves a thorough analysis of ICSR data available in Viatris’ global safety database, data from clinical studies, worldwide scientific literature, review of major health authorities websites and their publicly available safety database globally to collect as much information to evaluate any potential evidence supporting any association between the Product and a potential safety issue.”

    Source location

    Response from Viatris UK Healthcare Ltd
    Page 5 · response
    Published 31 July 2024

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Conduct routine pharmacovigilance, including case-report monitoring, literature review, signal assessment, regulatory reporting and periodic safety updates, with continued safety-profile assessment.

    Verbatim wording from the response

    “Viatris has a robust pharmacovigilance system in place in respect of all of its products, including Clozaril®. All reported suspected adverse reactions to the Product are evaluated by Viatris’ pharmacovigilance team (PV team). Viatris undertakes routine and continued monitoring of the benefit/risk balance of the Product.”

    Source location

    Response from Viatris UK Healthcare Ltd
    Page 3 · response
    Published 31 July 2024

    Open published response

    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

    Available evidence does not establish that clozapine increases the incidence of haematological malignancies.

    Verbatim wording from the response

    “3.11 As part of Viatris’ signal validation and assessment exercise, Viatris reviewed the literature and analysed the safety data that was relied upon in these two articles, and concluded that no causal relationship between haematologic malignancies and clozapine could be established by either study. This is consistent with the conclusions reached by the authors in both studies. When assessed holistically against the adverse event and safety information contained in Viatris’ safety database and the fact that there are no regulatory documents available on this topic, the signal was not validated (i.e. the “signal”: a potential link between an increased incidence of haematological malignancies and clozapine use, was not proven).”

    Source location

    Response from Viatris UK Healthcare Ltd
    Page 5 · response
    Published 31 July 2024

    Open published response

    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

    Ongoing pharmacovigilance and routine safety monitoring are considered sufficient, so no additional action is required.

    Verbatim wording from the response

    “3.12 Viatris’ assessment remains unchanged by the ongoing pharmacovigilance since the signal validation and assessment exercise in 2022. Accordingly no action is proposed.”

    Source location

    Response from Viatris UK Healthcare Ltd
    Page 6 · response
    Published 31 July 2024

    Open published response
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Published response patterns

Compared with other recipients in reports included in PFD Monitor

Describes published response evidence, not performance.

Published responses found

100%
100%All other recipients 58%
0%100%

How actions were described at the time

This respondent
100%
All other recipients
47%25%27%<1%<1%
  • Completed
  • In progress
  • Planned
  • Unclear
  • Partially completed

Statuses reflect what recipients said at the time. PFD Monitor does not verify whether actions happened.

Types of action described in responses

Percentages use all actions described by each group. An action may have more than one type, so percentages do not total 100%.

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

Data last updated 7 September 2026