PFD report

Miss Akua Anokye-Boateng · Prevention of Future Deaths report

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Issued 26 May 2014•Inner South London

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
1

Named on the report

Responses found
1

Of 1 recipient

Stated actions
3

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. Lack of clear best-practice guidance on gastro-intestinal protection during brief NSAID use in children with sickle disease
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 recipient says about a concern when it does not describe a specific action.2

  1. Position

    Current warnings and prescribing guidance are considered sufficient; the case does not warrant routine gastroprotection or changed warnings for children using NSAIDs.

    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 clear best-practice guidance on gastro-intestinal protection during brief NSAID use in children with sickle disease

Wider context from the report

“Expert evidence was heard from an experienced academic pathologist that one dose of NSAID was sufficient to damage the GI mucosa in children, which, coupled with a presumed Helicobacter infection, led in this case to the perforation. The consultant paediatrician with responsibility for haemoglobinopathies was unaware of the risk of a single dose in the past and gave evidence that Ibuprofen was an important drug in the management of sickle cell patients, having less side effects than opiates. He reported that it is not current practice to routinely give gastro-intestinal protection when NSAIDs are used briefly in children with sickle disease. Thus it is unclear what is best practice or whether the scientific evidence suggests that guidance is needed for clinicians about further precautions or prevention such as Proton pump inhibitors being routinely used alongside NSAIDs in children, to minimize the risk of similar deaths. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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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 warnings and prescribing guidance are considered sufficient; the case does not warrant routine gastroprotection or changed warnings for children using NSAIDs.

Verbatim wording from the response

“The SPCs for all POM non-selective NSAIDs include a recommendation to use gastro-protective agents (proton pump inhibitors or misoprostol) when prescribing NSAIDs to those at high risk of gastrointestinal side-effects, as follows:”

Source location

2014-0211-Response-by-Medicine-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 9 May 2014

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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 NSAID product information is considered sufficient to alert readers that serious gastrointestinal toxicity can occur early in treatment.

Verbatim wording from the response

“The SPCs for POM, P and GSL NSAIDs including ibuprofen state the following in section 4.4 (Special warnings and precautions for use):”

Source location

2014-0211-Response-by-Medicine-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 9 May 2014

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

    Review and implement strengthened patient information for all NSAIDs on gastrointestinal risks, symptom recognition, and actions to take if symptoms arise within 12 months.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 9 May 2014.
  2. 2

    Publish a Drug Safety Update article reminding healthcare professionals that NSAID gastrointestinal side effects can be serious, life-threatening, and occur after short-term use, including in children.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 9 May 2014.
  3. 3

    Implement gastrointestinal safety warnings and precautions in product information for prescription and non-prescription NSAIDs, including products authorised for children.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 9 May 2014.

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

  1. 1

    Routine PPI use is not included for over-the-counter ibuprofen because doses and indications are limited, with high-risk patients advised to consult doctors.

    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 respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Review and implement strengthened patient information for all NSAIDs on gastrointestinal risks, symptom recognition, and actions to take if symptoms arise within 12 months.

Verbatim wording from the response

“After careful consideration of the details of the case presented in your PFD report, the MHRA and its independent experts do not consider that this case changes the overall benefit-risk balance of ibuprofen in children or warrants a change to the current warnings about the need for gastro-protective agents for prescription only medicines. However, for all NSAIDs we will be strengthening the information for patients/parents provided in the package leaflet on the risk and recognition of gastrointestinal side effects and the action they should take.”

Source location

2014-0211-Response-by-Medicine-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 9 May 2014

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 a Drug Safety Update article reminding healthcare professionals that NSAID gastrointestinal side effects can be serious, life-threatening, and occur after short-term use, including in children.

Verbatim wording from the response

“The MHRA and its independent experts consider that this statement in the SPC is sufficient to alert readers to the possibility of serious gastrointestinal side effects occurring early in NSAID treatment. However, we acknowledge that healthcare professionals do not always read the SPC before prescribing, particularly when prescribing commonly used medicines, and your report highlights that there are some healthcare professionals who are unaware of this fact. Therefore we propose to inform and remind healthcare professionals about this through an article in the September 2014 issue of our monthly bulletin ‘Drug Safety Update’.”

Source location

2014-0211-Response-by-Medicine-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 9 May 2014

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

Implement gastrointestinal safety warnings and precautions in product information for prescription and non-prescription NSAIDs, including products authorised for children.

Verbatim wording from the response

“Following a number of national and Europe-wide reviews of the gastrointestinal safety of NSAIDs, a set of key elements was agreed for inclusion in the Summary of Product Characteristics (SPC) for all non-selective NSAIDs available as prescription only medicines (POM). These key elements include contraindications to use and extensive warnings in relation to the gastrointestinal side effects.”

Source location

2014-0211-Response-by-Medicine-Healthcare-Products-Regulatory-Agency
Page 1 · response
Published 9 May 2014

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

Routine PPI use is not included for over-the-counter ibuprofen because doses and indications are limited, with high-risk patients advised to consult doctors.

Verbatim wording from the response

“For non-prescription use of ibuprofen in adults and children, a recommendation for the concurrent use of PPIs is not included in the SPC. For those NSAIDs available over-the-counter, the authorised doses are lower than prescription-only products, and the indications only cover short term self-limiting conditions which do not require diagnosis & supervision by a medical practitioner. Patients (or parents of patients) at high risk of gastrointestinal side effects who purchase ibuprofen as an over-the-counter product are advised in the package leaflet to discuss taking these products with their doctor so that they can be properly advised about the need for gastro-protective medicines to be taken at the same time.”

Source location

2014-0211-Response-by-Medicine-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 9 May 2014

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