PFD report

Frederick William LE GRICE · Prevention of Future Deaths report

Pin Get email alerts Request correction

Issued 29 Sep 2023•Essex

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.

View original report
Concerns
3

Raised in this report

Recipients
1

Named on the report

Responses found
2

Of 1 recipient

Stated actions
3

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

Open published report

Concerns and recipient responses

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

Report evidence summary

Concerns raised3

  1. Lack of awareness among patients and clinicians of Nitrofurantoin lung-damage risk
  2. Risk of Nitrofurantoin-induced lung damage
  3. Failure to provide clear and effective guidance on Nitrofurantoin lung-damage warning symptoms
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.2

  1. Action

    Strengthen Nitrofurantoin respiratory-risk warnings in the Summary of Product Characteristics and Patient Information Leaflet.

    Stated by NHS EnglandStated completedThe respondent said that this action was complete when they made their response on 5 October 2023.
  2. Action

    Communicate strengthened Nitrofurantoin respiratory-risk warnings to healthcare professionals through a Drug Safety Update and an NHS England patient-safety case study.

    Stated by NHS EnglandStated completedThe respondent said that this action was complete when they made their response on 5 October 2023.

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

  1. Position

    The MHRA does not regulate additional prescribing advice sources, including NICE guidelines or local guidance.

    Stated by Department of Health and Social CareOutside remitThe respondent said that this matter was outside its role or authority.

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 awareness among patients and clinicians of Nitrofurantoin lung-damage risk

Wider context from the report

“(1) There is a known albeit rare side effect of Nitrofurantoin, of it causing lung damage. Nevertheless, neither the deceased himself, nor the clinicians involved in the deceased’s urinary care, who due to its specialism also have a prescribing function, were aware of the risk of lung damage from Nitrofurantoin. (2) It is not very clear in the guidance to general practitioners or patients generally, that the patient and the treating clinicians should be particularly alert to any signs of coughing or breathlessness, and that if they are present, it may well suggest that Nitrofurantoin is causing damage to the patient’s lungs. Such damage is likely to be irreversible. (3) I am concerned as to the effectiveness of the guidance and information available: (i) to general practitioners and prescribers treating those using urinary catheters and/or suffering from urinary tract infections; (ii) clinical staff in urology care; (iii) patients themselves Of the danger that Nitrofurantoin might cause lung damage, and (a) the need for all to be particularly vigilant as to symptoms and signs such as coughing or difficulty in breathing, and the desirability of their breathing and respiratory abilities being regularly monitored when a patient is using Nitrofurantoin (b) produce leaflets/information resources to that effect. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

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 Nitrofurantoin-induced lung damage

Wider context from the report

“(1) There is a known albeit rare side effect of Nitrofurantoin, of it causing lung damage. Nevertheless, neither the deceased himself, nor the clinicians involved in the deceased’s urinary care, who due to its specialism also have a prescribing function, were aware of the risk of lung damage from Nitrofurantoin. (2) It is not very clear in the guidance to general practitioners or patients generally, that the patient and the treating clinicians should be particularly alert to any signs of coughing or breathlessness, and that if they are present, it may well suggest that Nitrofurantoin is causing damage to the patient’s lungs. Such damage is likely to be irreversible. (3) I am concerned as to the effectiveness of the guidance and information available: (i) to general practitioners and prescribers treating those using urinary catheters and/or suffering from urinary tract infections; (ii) clinical staff in urology care; (iii) patients themselves Of the danger that Nitrofurantoin might cause lung damage, and (a) the need for all to be particularly vigilant as to symptoms and signs such as coughing or difficulty in breathing, and the desirability of their breathing and respiratory abilities being regularly monitored when a patient is using Nitrofurantoin (b) produce leaflets/information resources to that effect. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

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 provide clear and effective guidance on Nitrofurantoin lung-damage warning symptoms

Wider context from the report

“(1) There is a known albeit rare side effect of Nitrofurantoin, of it causing lung damage. Nevertheless, neither the deceased himself, nor the clinicians involved in the deceased’s urinary care, who due to its specialism also have a prescribing function, were aware of the risk of lung damage from Nitrofurantoin. (2) It is not very clear in the guidance to general practitioners or patients generally, that the patient and the treating clinicians should be particularly alert to any signs of coughing or breathlessness, and that if they are present, it may well suggest that Nitrofurantoin is causing damage to the patient’s lungs. Such damage is likely to be irreversible. (3) I am concerned as to the effectiveness of the guidance and information available: (i) to general practitioners and prescribers treating those using urinary catheters and/or suffering from urinary tract infections; (ii) clinical staff in urology care; (iii) patients themselves Of the danger that Nitrofurantoin might cause lung damage, and (a) the need for all to be particularly vigilant as to symptoms and signs such as coughing or difficulty in breathing, and the desirability of their breathing and respiratory abilities being regularly monitored when a patient is using Nitrofurantoin (b) produce leaflets/information resources to that effect. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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

Strengthen Nitrofurantoin respiratory-risk warnings in the Summary of Product Characteristics and Patient Information Leaflet.

Verbatim wording from the response

“The National Patient Safety and Antimicrobial Resistance Teams at NHS England worked closely on this issue with the Medicines and Healthcare products Regulatory Agency (MHRA). This has culminated in the wording in both the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL) for Nitrofurantoin being updated and strengthened to emphasise the need for vigilance of emerging respiratory symptoms during treatment and to ensure that these warnings are prominent. The SmPC is used by healthcare professionals such as GPs and pharmacists for guidance on how to use and prescribe a medicine and a PIL must be given to all patients with information on their medications when they receive them.”

Source location

Response from NHS England
Page 1 · response
Published 5 October 2023

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

Communicate strengthened Nitrofurantoin respiratory-risk warnings to healthcare professionals through a Drug Safety Update and an NHS England patient-safety case study.

Verbatim wording from the response

“Subsequently, the updates were also communicated to healthcare professionals via a MHRA Drug Safety Update on 26 April 2023. This work is also highlighted in an NHS England Patient Safety Case Study in August 2023.”

Source location

Response from NHS England
Page 1 · response
Published 5 October 2023

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 MHRA does not regulate additional prescribing advice sources, including NICE guidelines or local guidance.

Verbatim wording from the response

“The MHRA is an Executive Agency of the Department of Health and Social Care (DHSC) with responsibility for the regulation of medicinal products in the UK. The MHRA ensures that medicines are efficacious and acceptably safe, and that any possible side effects which have been recognised to occur with use of a medicine are appropriately described in the authorised product information. This comprises the Summary of Product Characteristics (SmPC, intended for healthcare professionals), labelling, and Patient Information Leaflet (PIL, provided to patients in each medicine pack). The MHRA does not regulate any additional sources of advice healthcare professionals may use when prescribing medicines, such as NICE (National Institute for Health and Care Excellence) guidelines or any local guidance.”

Source location

Response from Department of Health and Social Care
Page 2 · response
Published 5 October 2023

Open published response

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.1

  1. 1

    Discuss Prevention of Future Deaths reports through the Regulation 28 Working Group and share resulting patient-safety learning across national and regional NHS services.

    Stated by NHS EnglandStated completedThe respondent said that this action was complete when they made their response on 5 October 2023.

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

Discuss Prevention of Future Deaths reports through the Regulation 28 Working Group and share resulting patient-safety learning across national and regional NHS services.

Verbatim wording from the response

“I would also like to provide further assurances on national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around preventable deaths are shared across the NHS at both a national and regional level and helps us pay close attention to any emerging trends that may require further review and action.”

Source location

Response from NHS England
Page 2 · response
Published 5 October 2023

Open published response
Back to top

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

Official responses located
2/1

Data last updated 7 September 2026