Recurring concern

Failure to recognise medication-related pulmonary toxicity

First to latest report 30 Sep 2019 — 19 Aug 2025

Reports that mention this concern: 3
Times this concern has been raised: 5
Stated actions linked to this concern: 7

What this concern includes

Includes failures of clinical recognition, prescribing safeguards, decision support, alerts, guidance or communication specifically intended to identify and act on pulmonary toxicity or pulmonary fibrosis caused or potentially caused by a medication or therapy.

What is not included

Excludes pulmonary conditions unrelated to medication or therapy.
Excludes general medication-safety, prescribing or adverse-event-reporting failures where pulmonary toxicity is not the identified risk.
Excludes failures in treatment after medication-related pulmonary toxicity has been reliably recognised and communicated.
Excludes generic training, communication or documentation deficiencies unless they directly impair recognition or communication of medication-related pulmonary toxicity.

Trends

Reports over time

Reports mentioning this concern, over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Reports about this concern sent to each recipient.

Claypath and University Medical Group1

Egton Medical Information Systems Limited1

Greater Manchester Health and Social Care Partnership1

Medicines and Healthcare products Regulatory Agency1

National Institute for Health and Care Excellence1

NHS Greater Manchester Integrated Care Board1

Park View Group Practice1

Royal Pharmaceutical Society1

Reports and published responses 3 reports

See individual reports that have raised this concern, and the actions taken in response

19 Aug2025
Surrey
Concerns raised3
1. Failure of nitrofurantoin safety alert criteria to cover patients without pre-existing pulmonary disease
2. Failure of the surgery EMIS system to display MHRA nitrofurantoin safety alerts
3. Limited clinician awareness of nitrofurantoin pulmonary damage and respiratory failure in elderly patients
Linked response

Optum
Respondent positions 1
1. Optum
  Existing EMIS Web functionality is considered sufficient to mitigate the specific MHRA Nitrofurantoin risk; no further software development is required.
  Existing arrangements considered sufficient
AI-generated summary

Venetia Clarissa Pierce · 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

Venetia Clarissa Pierce, described as an elderly frail lady with recurrent urinary infections, was prescribed nitrofurantoin prophylactically in February 2024 and died in hospital on 30 December 2024. The inquest recorded nitrofurantoin-induced pneumonitis as the medical cause of death, with frailty contributing. Concerns included the absence of an MHRA safety alert on the surgery’s EMIS system and limited awareness among clinicians of the potential for pulmonary damage and respiratory failure from nitrofurantoin in elderly patients.

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.
PFD Monitor interpretation
Failure of nitrofurantoin safety alert criteria to cover patients without pre-existing pulmonary disease
Wider context from the report
“a. The MHRA issued a drug safety alert regarding the risks of pulmonary and hepatic adverse drug reactions in relation to nitrofurantoin in April 2023. However, no MHRA safety alert appeared on the surgery EMIS system when the drug was prescribed to Mrs Pierce. The court heard that the safety alert only arises when patients have a pre-existing pulmonary disease which Mrs Pierce did not have. ”
Source location
Venetia Clarissa Pierce · Prevention of Future Deaths report
Page 3 · concerns
Open source report
Source evidence
How this individual concern was interpreted
PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation
Failure of the surgery EMIS system to display MHRA nitrofurantoin safety alerts
Wider context from the report
“a. The MHRA issued a drug safety alert regarding the risks of pulmonary and hepatic adverse drug reactions in relation to nitrofurantoin in April 2023. However, no MHRA safety alert appeared on the surgery EMIS system when the drug was prescribed to Mrs Pierce. The court heard that the safety alert only arises when patients have a pre-existing pulmonary disease which Mrs Pierce did not have. ”
Source location
Venetia Clarissa Pierce · Prevention of Future Deaths report
Page 3 · concerns
Open source report
Source evidence
How this individual concern was interpreted
PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation
Limited clinician awareness of nitrofurantoin pulmonary damage and respiratory failure in elderly patients
Wider context from the report
“b. Although a “recognised” complication, understanding of the potential for pulmonary damage and respiratory failure from use of nitrofurantoin in the elderly may remain low. The court heard evidence from a respiratory consultant that awareness amongst GPs, hospital clinicians including urologists was limited and that even if Mrs Pierce had been referred to hospital earlier the condition might not have been diagnosed. ”
Source location
Venetia Clarissa Pierce · Prevention of Future Deaths report
Page 3 · concerns
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
Existing EMIS Web functionality is considered sufficient to mitigate the specific MHRA Nitrofurantoin risk; no further software development is required.

Verbatim wording from the response
“In this instance, based on the information provided in the Report, and our subsequent review, we do not believe there are any software developments beyond the existing functionality in the System that are required to mitigate the specific risk raised in the Report.”

Source location
Response from EMIS
Page 2 · response
Published 29 August 2025
Open published response
7 Mar2022
County Durham and Darlington
Concerns raised1
1. Failure of nitrofurantoin prescribing guidance to provide advice on monitoring for sudden pulmonary deterioration during short-term treatment in elderly patients
Linked responses

Claypath and University Medical Group
Medicines and Healthcare products Regulatory Agency
National Institute for Health and Care Excellence
Royal Pharmaceutical Society
Stated actions 7
1. Medicines and Healthcare products Regulatory Agency
  Review evidence on nitrofurantoin pulmonary adverse reactions and obtain expert advice on whether product information should be amended.
2. Medicines and Healthcare products Regulatory Agency
  Request marketing authorisation holders to strengthen and prominently emphasise respiratory warnings in nitrofurantoin product information for healthcare professionals and patients.
3. Medicines and Healthcare products Regulatory Agency
  Communicate nitrofurantoin product-information updates to the BNF so its monograph can be revised as needed.
1. Medicines and Healthcare products Regulatory Agency
  Publish an MHRA Drug Safety Update article informing UK healthcare professionals about nitrofurantoin pulmonary risks, respiratory symptoms, investigation and prompt reporting.
2. Claypath and University Medical Group
  Alert prescribing clinicians to nitrofurantoin’s serious breathlessness side effects and the need for prompt patient reporting.
3. Claypath and University Medical Group
  Write to the Local Medicine Management Team highlighting nitrofurantoin’s life-threatening side effect.
4. Royal Pharmaceutical Society
  Update the nitrofurantoin monograph with highlighted information on acute pulmonary reactions, including patient counselling and prompt symptom reporting.
Respondent positions 4
1. Medicines and Healthcare products Regulatory Agency
  The BNF is outside the MHRA’s responsibility, so the MHRA will not directly amend its monograph.
  Outside remit
1. Medicines and Healthcare products Regulatory Agency
  The BNF is expected to further revise its nitrofurantoin monograph as needed after receiving updated product information.
  Redirects responsibility
2. National Institute for Health and Care Excellence
  Responsibility for BNF content remains with its publishers, so the matter is outside NICE’s authority to comment on or amend.
  Outside remit
3. National Institute for Health and Care Excellence
  The Royal Pharmaceutical Society is better placed to respond to concerns about the BNF entry for nitrofurantoin.
  Redirects responsibility
AI-generated summary

Jane Elizabeth ALLISON · 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

Jane Elizabeth ALLISON died in hospital on 20 November 2021 after being admitted with severe type 1 respiratory failure. She had received a 10-day course of nitrofurantoin for a urinary tract infection, and the inquest concluded that she died from the effects of prescribed medication. The principal concern was that BNF guidance did not sufficiently alert clinicians to the risk of sudden pulmonary deterioration or provide adequate monitoring advice in this circumstance.

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.
PFD Monitor interpretation
Failure of nitrofurantoin prescribing guidance to provide advice on monitoring for sudden pulmonary deterioration during short-term treatment in elderly patients
Wider context from the report
“In effect, my concern is that the BNF content had not advised to be alerted to the danger of sudden pulmonary deterioration in an elderly patient, and certainly not one who was fit and active, and not in the context of the duration of a prescribing, dispensing and administration period of only 10 days. Effectively, the BNF content did not cover the eventuality of this case in that it was deficient in providing advice as to monitoring and being alert for pulmonary failure. ”
Source location
Jane Elizabeth ALLISON · Prevention of Future Deaths report
Page 1 · concerns
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
Review evidence on nitrofurantoin pulmonary adverse reactions and obtain expert advice on whether product information should be amended.

Verbatim wording from the response
“As you have noted, the product information for nitrofurantoin does list pulmonary and respiratory issues as possible side effects. We have conducted a review of the available evidence concerning nitrofurantoin and pulmonary adverse drug reactions and sought expert advice from the Pharmacovigilance Expert Advisory Group (PEAG) of the Commission on Human Medicines on the”

Source location
Response from MHRA
Page 1 · response
Published 8 March 2022
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
Request marketing authorisation holders to strengthen and prominently emphasise respiratory warnings in nitrofurantoin product information for healthcare professionals and patients.

Verbatim wording from the response
“In summary, we have considered the available evidence on nitrofurantoin and acute pulmonary reactions and, based on expert advice from the PEAG, will request that Marketing Authorisation Holders (MAHs) strengthen the wording in the UK Summary of Product Information (SmPC) and Patient Information Leaflet (PIL).”

Source location
Response from MHRA
Page 2 · response
Published 8 March 2022
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 nitrofurantoin product-information updates to the BNF so its monograph can be revised as needed.

Verbatim wording from the response
“We are aware that the BNF, which is not the responsibility of the MHRA, has recently updated the nitrofurantoin monograph. These updates, adding additional information on acute pulmonary reactions, are in line with the current UK SmPC and PIL. The MHRA will communicate any SmPC and PIL updates, to the BNF, so that they can further revise their monograph as needed.”

Source location
Response from MHRA
Page 2 · response
Published 8 March 2022
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
Publish an MHRA Drug Safety Update article informing UK healthcare professionals about nitrofurantoin pulmonary risks, respiratory symptoms, investigation and prompt reporting.

Verbatim wording from the response
“The PEAG also agreed that it would be appropriate to communicate to UK healthcare professionals to inform them of these updates and remind them of the potential for pulmonary and chronic adverse drug reactions in association with nitrofurantoin, and that any such symptoms should be investigated and reported promptly. The PEAG considered that an article in the MHRA’s monthly ‘Drug Safety Update’ bulletin may be an appropriate method to communicate these messages, and we will be taking this forward.”

Source location
Response from MHRA
Page 2 · response
Published 8 March 2022
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
Alert prescribing clinicians to nitrofurantoin’s serious breathlessness side effects and the need for prompt patient reporting.

Verbatim wording from the response
“1. An email has been sent to all prescribing clinicians alerting them to the rare but significant and potentially life-threatening side effects of nitrofurantoin causing acute breathlessness and the need to advise patients to promptly report such symptoms.”

Source location
Response from Claypath and University Medical Group
Page 1 · response
Published 8 March 2022
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
Write to the Local Medicine Management Team highlighting nitrofurantoin’s life-threatening side effect.

Verbatim wording from the response
“4. One of our partners has agreed to write to the Local Medicine Management Team highlighting this life-threatening side effect and expecting possible changes to the local guidelines.”

Source location
Response from Claypath and University Medical Group
Page 1 · response
Published 8 March 2022
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
Update the nitrofurantoin monograph with highlighted information on acute pulmonary reactions, including patient counselling and prompt symptom reporting.

Verbatim wording from the response
“We have reviewed the BNF content for nitrofurantoin in response to your report and can confirm that we will add additional information regarding acute pulmonary reactions to the nitrofurantoin monograph in the BNF. To increase awareness of this side-effect, we will highlight it specifically in an additional section of the side-effects information. We will also add information on the importance of counselling patients on the possible symptoms of acute pulmonary reactions and the necessity of promptly reporting such symptoms. This will mean that the risk of acute pulmonary reactions will be highlighted in the nitrofurantoin monograph in future.”

Source location
2022-0071-Response-from-Royal-Pharmaceutical-Society_Published
Page 1 · response
Published 8 March 2022
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 BNF is outside the MHRA’s responsibility, so the MHRA will not directly amend its monograph.

Verbatim wording from the response
“We are aware that the BNF, which is not the responsibility of the MHRA, has recently updated the nitrofurantoin monograph. These updates, adding additional information on acute pulmonary reactions, are in line with the current UK SmPC and PIL. The MHRA will communicate any SmPC and PIL updates, to the BNF, so that they can further revise their monograph as needed.”

Source location
Response from MHRA
Page 2 · response
Published 8 March 2022
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 BNF is expected to further revise its nitrofurantoin monograph as needed after receiving updated product information.

Verbatim wording from the response
“We are aware that the BNF, which is not the responsibility of the MHRA, has recently updated the nitrofurantoin monograph. These updates, adding additional information on acute pulmonary reactions, are in line with the current UK SmPC and PIL. The MHRA will communicate any SmPC and PIL updates, to the BNF, so that they can further revise their monograph as needed.”

Source location
Response from MHRA
Page 2 · response
Published 8 March 2022
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
Responsibility for BNF content remains with its publishers, so the matter is outside NICE’s authority to comment on or amend.

Verbatim wording from the response
“The BNF is a joint publication of BMJ Group and Pharmaceutical Press, the publishing division of the Royal Pharmaceutical Society. While we make the BNF available on the NICE website, responsibility for the content remains with the publishers and therefore NICE cannot comment on the concerns you have raised.”

Source location
2022-0071-Response-from-NICE_Published
Page 1 · response
Published 8 March 2022
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 Royal Pharmaceutical Society is better placed to respond to concerns about the BNF entry for nitrofurantoin.

Verbatim wording from the response
“I am aware that your report has also been sent to the chief executive of the Royal Pharmaceutical Society who will be better placed to respond to your concerns.”

Source location
2022-0071-Response-from-NICE_Published
Page 1 · response
Published 8 March 2022
Open published response
30 Sep2019
Manchester South
Concerns raised1
1. Failure of GPs to recognise the link between the therapy and Pulmonary Fibrosis
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
No linked response statements
No respondent-stated action or position is linked to these concerns in the published data.
AI-generated summary

Graham Earl · 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

Graham Earl had pulmonary fibrosis diagnosed while receiving Amiodarone therapy and was not referred back to the cardiologist. He later developed influenza, deteriorated, and died at Stepping Hill Hospital on 16 February 2019. The principal concerns were that the link between Amiodarone and pulmonary fibrosis was not recognised promptly, the medication was amended without reference to secondary care, and there was insufficient awareness of escalation procedures for side effects.

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.
PFD Monitor interpretation
Failure of GPs to recognise the link between the therapy and Pulmonary Fibrosis
Wider context from the report
“1. The GPs involved did not understand or recognise the known link between the therapy and Pulmonary Fibrosis and did not seek guidance from the prescribing secondary care physician at an early stage. The evidence was that the advice would have been to stop prescribing immediately; ”
Source location
Graham Earl · Prevention of Future Deaths report
Page 2 · concerns
Open source report

Actions and positions describe what organisations say in published responses. Implementation is not independently verified.

Data last updated 7 September 2026

What this concern includes

Trends

Reports mentioning this concern, over time

Concerns raised3

Failure of nitrofurantoin safety alert criteria to cover patients without pre-existing pulmonary disease

Failure of the surgery EMIS system to display MHRA nitrofurantoin safety alerts

Limited clinician awareness of nitrofurantoin pulmonary damage and respiratory failure in elderly patients

Linked response

Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.1

Concerns raised1

Failure of nitrofurantoin prescribing guidance to provide advice on monitoring for sudden pulmonary deterioration during short-term treatment in elderly patients

Linked responses

Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.7

Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.4

Concerns raised1

Failure of GPs to recognise the link between the therapy and Pulmonary Fibrosis

Respondent positions 1

Stated actions 7

Respondent positions 4