PFD report

Samuel David Morgan · Prevention of Future Deaths report

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Issued 9 Dec 2020•Swansea and Neath Port Talbot

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
2

Named on the report

Responses found
2

Of 2 recipients

Stated actions
7

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Concerns raised1

  1. Lack of immediate, prominent medication warnings about increased suicidal thinking risk in young adults
    Part of recurring concern: Inadequate safety warnings on medication packaging
Responses linked to these concerns

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

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.1

  1. Action

    Implement and user-test prominent SSRI patient-information warnings about suicidal thoughts and behaviour.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 5 January 2021.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.3

  1. Position

    Current UK headlines and emboldened patient-information warnings are considered sufficient because no evidence shows US black-box warnings communicate risk more effectively.

    Stated by Medicines and Healthcare products Regulatory AgencyExisting 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

Lack of immediate, prominent medication warnings about increased suicidal thinking risk in young adults

Wider context from the report

“Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely and allows patients to read at their leisure. However, it has been suggested that the “Black Box Warning” (as developed by the Food and Drug Administration in the USA) would have a more immediate impact and capture some patient’s attention highlighting any risks. The simple and clear message in this specific case would be that there is an increased risk of suicidal thinking in young adults. The benefits of such simple and direct messaging extends to all prescribed medicines and associated major risks. ”

Is this part of a recurring concern?

Yes — Inadequate safety warnings on medication packaging.

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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

Implement and user-test prominent SSRI patient-information warnings about suicidal thoughts and behaviour.

Verbatim wording from the response

“Citalopram is an antidepressant that belongs to the selective serotonin reuptake inhibitor (SSRI) class of medicines. The current warnings about the known risk of suicide with use of SSRI antidepressants were implemented following UK and European reviews of the evidence. The text agreed for the patient information leaflet (PIL) was developed with patients’ input and was subject to user testing.”

Source location

2020-0276-Response-from-MHRA-Redacted
Page 1 · response
Published 5 January 2021

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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 UK headlines and emboldened patient-information warnings are considered sufficient because no evidence shows US black-box warnings communicate risk more effectively.

Verbatim wording from the response

“We have taken note of your suggestion that the “black box” warnings in the US product information of suicide warnings for patients ‘would have a more immediate impact’, however we are unable to find evidence that this is more effective in communicating risk than the current practice in the UK of headlines and emboldened text supported by extensive user testing to shape the presentation of key safety messages. Should new data come to light we will review this and see what changes could be made to support risk communication in the future.”

Source location

2020-0276-Response-from-MHRA-Redacted
Page 2 · response
Published 5 January 2021

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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

The MHRA has found no evidence that United States-style black-box warnings communicate medicine risks more effectively than UK patient information leaflets.

Verbatim wording from the response

“My officials have liaised with the Medicines and Healthcare products Regulatory Agency (MHRA) which I know has considered carefully your comments about the presentation of risks associated with citalopram and other selective serotonin reuptake inhibitor (SSRI) medicines on Patient Information Leaflets, and by extension the presentation of major risks associated with all prescribed medicines.”

Source location

2020-0276-Response-from-Dept.-of-Health-and-Social-Care-Redacted
Page 1 · response
Published 5 January 2021

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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

Existing NICE, product information, BNF and MHRA guidance is considered adequate to inform SSRI risk discussions and monitoring, particularly when treatment begins.

Verbatim wording from the response

“Clinicians are expected to take account of NICE guidelines, product information and advice in the BNF when discussing treatment options with a patient, ensuring that patients are aware of known risks associated with medicines so that properly informed decisions are taken. The risk of suicidal behaviour associated with SSRIs, particularly in young people aged up to 25 years, has been highlighted to healthcare professionals via MHRA Drug Safety Updates, as well as in published guidance by the MHRA². The GP handbook, the British National Formulary (BNF) also highlights these risks and the importance of monitoring particularly at the start of treatment.”

Source location

2020-0276-Response-from-Dept.-of-Health-and-Social-Care-Redacted
Page 2 · response
Published 5 January 2021

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Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.6

  1. 1

    Inform UK healthcare professionals about SSRI-associated suicidal behaviour through Drug Safety Update bulletin articles.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 5 January 2021.
  2. 2

    Publish prescriber guidance summarising key SSRI and SNRI safety messages on the MHRA webpage.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 5 January 2021.
  3. 3

    Issue guidance urging local authorities to coordinate local services, including voluntary organisations, to target high-risk groups such as men.

    Stated by Department of Health and Social CareStated completedThe respondent said that this action was complete when they made their response on 5 January 2021.
  4. 4

    Ensure local suicide-prevention funding tests approaches to reaching and engaging men.

    Stated by Department of Health and Social CareStated completedThe respondent said that this action was complete when they made their response on 5 January 2021.
  5. 5

    Continue suicide-prevention action through England’s strategy, progress reports and cross-Government workplan.

    Stated by Department of Health and Social CareStated in progressThe respondent said that this action was in progress when they made their response on 5 January 2021.
  6. 6

    Invest £57 million through the NHS Long Term Plan to support local suicide-prevention plans and establish suicide-bereavement support services by 2023/24.

    Stated by Department of Health and Social CareStated in progressThe respondent said that this action was in progress when they made their response on 5 January 2021.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.1

  1. 1

    The prescription’s alleged contravention of NICE guidance should be pursued with NICE or the General Medical Council.

    Stated by Medicines and Healthcare products Regulatory AgencyRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.

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

Inform UK healthcare professionals about SSRI-associated suicidal behaviour through Drug Safety Update bulletin articles.

Verbatim wording from the response

“To supplement the patient information, the MHRA has informed healthcare professionals in the UK about the risk of suicidal behaviour associated with SSRIs via articles in the MHRA’s bulletin Drug Safety Update in April 2008 and December 2014 available at https://www.gov.uk/drug-safety-update/antidepressants-suicidal-thoughts-and-behaviour.”

Source location

2020-0276-Response-from-MHRA-Redacted
Page 2 · response
Published 5 January 2021

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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

Publish prescriber guidance summarising key SSRI and SNRI safety messages on the MHRA webpage.

Verbatim wording from the response

“We also published guidance for prescribers on the MHRA webpage in December 2014 to summarise key safety messages (https://www.gov.uk/government/publications/ssris-snris-use-and-safety/selective-serotonin-reuptake-inhibitors-ssris-and-serotonin-and-noradrenaline-reuptake-inhibitors-snris-use-and-safety).”

Source location

2020-0276-Response-from-MHRA-Redacted
Page 2 · response
Published 5 January 2021

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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

Issue guidance urging local authorities to coordinate local services, including voluntary organisations, to target high-risk groups such as men.

Verbatim wording from the response

“We have issued guidance to local authorities that highlights the importance of working across all local services, including the voluntary sector, to target high risk groups such as men. Every local authority now has a suicide prevention plan in place and 97 per cent of these include action to reduce risk of suicide in men.”

Source location

2020-0276-Response-from-Dept.-of-Health-and-Social-Care-Redacted
Page 2 · response
Published 5 January 2021

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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

Ensure local suicide-prevention funding tests approaches to reaching and engaging men.

Verbatim wording from the response

“From 2019/20, we are investing £57million in suicide prevention through the NHS Long Term Plan. This will see investment in all areas of the country by 2023/24 to support local suicide prevention plans and establish suicide bereavement support services. We have ensured that the suicide prevention funding for local areas is used to test different approaches to reaching and engaging men.”

Source location

2020-0276-Response-from-Dept.-of-Health-and-Social-Care-Redacted
Page 2 · response
Published 5 January 2021

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

Continue suicide-prevention action through England’s strategy, progress reports and cross-Government workplan.

Verbatim wording from the response

“In England, suicide prevention is a priority for this Government and we continue to take action through the Suicide Prevention Strategy for England and its subsequent progress reports, as well as through the first cross-Government Suicide Prevention Workplan, which sets out an ambitious programme across national and local Government and the NHS to reduce suicides.”

Source location

2020-0276-Response-from-Dept.-of-Health-and-Social-Care-Redacted
Page 1 · response
Published 5 January 2021

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

Invest £57 million through the NHS Long Term Plan to support local suicide-prevention plans and establish suicide-bereavement support services by 2023/24.

Verbatim wording from the response

“From 2019/20, we are investing £57million in suicide prevention through the NHS Long Term Plan. This will see investment in all areas of the country by 2023/24 to support local suicide prevention plans and establish suicide bereavement support services. We have ensured that the suicide prevention funding for local areas is used to test different approaches to reaching and engaging men.”

Source location

2020-0276-Response-from-Dept.-of-Health-and-Social-Care-Redacted
Page 2 · response
Published 5 January 2021

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

The prescription’s alleged contravention of NICE guidance should be pursued with NICE or the General Medical Council.

Verbatim wording from the response

“In addition, clinical guidance issued by the National Institute for Health and Care Excellence (NICE) (Clinical Guideline 90, CG90) on depression in adults recommends that if a person with depression is started on antidepressants and is considered to be an increased suicide risk or is younger than 30 years (because of the potential increased prevalence of suicidal thoughts in the early stages of antidepressant treatment for this group) they should normally be seen after 1 week and frequently thereafter as appropriate until the risk is no longer considered clinically important. I am unable to comment on the issue of the prescription for Mr Morgan to be in contravention of NICE guidance you refer to in the report. Should you wish to follow this up please do contact NICE directly or raise with the General Medical Council.”

Source location

2020-0276-Response-from-MHRA-Redacted
Page 2 · response
Published 5 January 2021

Open published response
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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