First reported 30 Sep 2019•Latest report 19 Aug 2025
Definition
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.
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.
Reports
3
Distinct published reports
Individual concerns
5
A report can raise multiple concerns
Date range
2019–2025
First to latest report issue date
Stated actions
7
Described in published responses
Reports over time
Reports over time
Reports about this concern issued each year.
* 2026 is projected from reports observed to 7 Sep 2026.
Most frequent recipients
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
Healthcare site2
Executive non-departmental public body1
Health professional body1
Health-system partnership1
Integrated care board1
Medicines and medical devices regulator1
Private limited company1
Concerns and responses across reports
Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.
Surrey
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
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.1
Position
Existing EMIS Web functionality is considered sufficient to mitigate the specific MHRA Nitrofurantoin risk; no further software development is required.
Stated by OptumExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
County Durham and Darlington
Concerns raised1
Failure of nitrofurantoin prescribing guidance to provide advice on monitoring for sudden pulmonary deterioration during short-term treatment in elderly patients
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 respondent says it has done, is doing, or plans to do in response to the concern raised.7
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.
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.
Action
Communicate nitrofurantoin product-information updates to the BNF so its monograph can be revised as needed.
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.
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.
Action
Alert prescribing clinicians to nitrofurantoin’s serious breathlessness side effects and the need for prompt patient reporting.
Stated by Claypath and University Medical GroupStated completedThe respondent said that this action was complete when they made their response on 8 March 2022.
Action
Write to the Local Medicine Management Team highlighting nitrofurantoin’s life-threatening side effect.
Stated by Claypath and University Medical GroupStated plannedThe respondent said that this action was planned when they made their response on 8 March 2022.
Action
Update the nitrofurantoin monograph with highlighted information on acute pulmonary reactions, including patient counselling and prompt symptom reporting.
Stated by Royal Pharmaceutical SocietyStated plannedThe respondent said that this action was planned when they made their response on 8 March 2022.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.4
Position
The BNF is outside the MHRA’s responsibility, so the MHRA will not directly amend its monograph.
Stated by Medicines and Healthcare products Regulatory AgencyOutside remitThe respondent said that this matter was outside its role or authority.
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.
Position
Responsibility for BNF content remains with its publishers, so the matter is outside NICE’s authority to comment on or amend.
Stated by National Institute for Health and Care ExcellenceOutside remitThe respondent said that this matter was outside its role or authority.
Position
The Royal Pharmaceutical Society is better placed to respond to concerns about the BNF entry for nitrofurantoin.
Stated by National Institute for Health and Care ExcellenceRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Manchester South
Concerns raised1
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.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements
No respondent-stated action or position is linked to these concerns in the published data.
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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.
