PFD report

Jane Elizabeth ALLISON · Prevention of Future Deaths report

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Issued 7 Mar 2022•County Durham and Darlington

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
3

Named on the report

Responses found
4

Of 3 recipients

Stated actions
10

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 raised1

  1. Failure of nitrofurantoin prescribing guidance to provide advice on monitoring for sudden pulmonary deterioration during short-term treatment in elderly patients
    Part of recurring concern: Failure to recognise medication-related pulmonary toxicityPart of recurring concern: Incomplete medication safety guidance for prescribers
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.7

  1. Action

    Review evidence on nitrofurantoin pulmonary adverse reactions and obtain expert advice on whether product information should be amended.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 8 March 2022.
  2. Action

    Publish an MHRA Drug Safety Update article informing UK healthcare professionals about nitrofurantoin pulmonary risks, respiratory symptoms, investigation and prompt reporting.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 8 March 2022.
  3. Action

    Request marketing authorisation holders to strengthen and prominently emphasise respiratory warnings in nitrofurantoin product information for healthcare professionals and patients.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 8 March 2022.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.4

  1. Position

    The BNF is expected to further revise its nitrofurantoin monograph as needed after receiving updated product information.

    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 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 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. ”

Is this part of a recurring concern?

Yes — Failure to recognise medication-related pulmonary toxicity; Incomplete medication safety guidance for prescribers.

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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

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

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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 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

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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

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

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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

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

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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

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

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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

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

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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

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

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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 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

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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 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

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

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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 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

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.3

  1. 1

    Continue close review of nitrofurantoin and acute pulmonary reactions.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 8 March 2022.
  2. 2

    Discuss nitrofurantoin safety learning at the next Significant Event Analysis Meeting.

    Stated by Claypath and University Medical GroupStated plannedThe respondent said that this action was planned when they made their response on 8 March 2022.
  3. 3

    Investigate information-technology options for providing patients with written information about nitrofurantoin side effects.

    Stated by Claypath and University Medical GroupStated in progressThe respondent said that this action was in progress when they made their response on 8 March 2022.

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

  1. 1

    The Medicines and Healthcare products Regulatory Agency should be contacted regarding nitrofurantoin’s summary of product characteristics.

    Stated by National Institute for Health and Care ExcellenceRedirects 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

Continue close review of nitrofurantoin and acute pulmonary reactions.

Verbatim wording from the response

“We will continue to keep the issue of nitrofurantoin and acute pulmonary reactions under close review, and we will let you know when the product information updates are complete and the Drug Safety Update Bulletin has been issued.”

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

Discuss nitrofurantoin safety learning at the next Significant Event Analysis Meeting.

Verbatim wording from the response

“2. We will discuss this further in our next Significant Event Analysis Meeting.”

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

Investigate information-technology options for providing patients with written information about nitrofurantoin side effects.

Verbatim wording from the response

“3. We are also looking into our information technology to help us give written information to the patients about the side effects of this medication.”

Source location

Response from Claypath and University Medical Group
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 Medicines and Healthcare products Regulatory Agency should be contacted regarding nitrofurantoin’s summary of product characteristics.

Verbatim wording from the response

“You may also wish to contact the Medicines and Healthcare products Regulatory Authority (MHRA) with respect to the summary of product characteristics for nitrofurantoin.”

Source location

2022-0071-Response-from-NICE_Published
Page 1 · response
Published 8 March 2022

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

Official responses located
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Data last updated 7 September 2026