PFD report

Raymond Charles Woodward · Prevention of Future Deaths report

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Issued 26 Aug 2016•Birmingham and Solihull

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
3

Raised in this report

Recipients
1

Named on the report

Responses found
1

Of 1 recipient

Stated actions
4

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 raised3

  1. Lack of widespread awareness of the risk of adverse reactions to Buscopan in coronary artery disease
  2. Failure of intravenous Buscopan cardiovascular warnings to specifically encompass ischaemic heart disease
    Part of recurring concern: Inadequate product safety warnings about serious hazards
  3. Failure to alert the wider medical community to potential cardiovascular problems with intravenous Buscopan
    Part of recurring concern: Unreliable dissemination of safety alerts to relevant recipients
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.4

  1. Action

    Communicate the revised Buscopan safety recommendations to healthcare professionals through the MHRA Drug Safety Update newsletter.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 26 August 2016.
  2. Action

    Revise the Buscopan Ampoules Summary of Product Characteristics to strengthen warnings about serious adverse reactions in patients with cardiac disease.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 26 August 2016.
  3. Action

    Analyse reported UK deaths suspected to involve Buscopan Ampoules and review the current product information to determine necessary regulatory action.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 26 August 2016.

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 widespread awareness of the risk of adverse reactions to Buscopan in coronary artery disease

Wider context from the report

“(1) The risk of an adverse reaction to Buscopan in the presence of coronary artery disease is not widely known despite the wide use of Buscopan. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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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 intravenous Buscopan cardiovascular warnings to specifically encompass ischaemic heart disease

Wider context from the report

“(2) The SPC relating to the use of intravenous Buscopan references the following in relation to the cardiovascular system – ‘Buscopan Ampoules should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery where it may further accelerate the heart rate’. (3) The term ‘cardiac insufficiency’ is unwieldy and does not immediately relate to a specific diagnosis, lacks specificity and does not necessarily encompass those patients with ischaemic heart disease. ”

Is this part of a recurring concern?

Yes — Inadequate product safety warnings about serious hazards.

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 alert the wider medical community to potential cardiovascular problems with intravenous Buscopan

Wider context from the report

“(4) ████████ the Deceased’s Consultant Physician and Gastroenterologist, gave firm evidence, having extensively researched the issue, that the wider medical community needs to be alerted to potential cardiovascular problems in using IV Buscopan and this could be achieved by incorporating into the SPC ‘additional caution should be exercised in administering IV Buscopan to patients with ischaemic heart disease’. ”

Is this part of a recurring concern?

Yes — Unreliable dissemination of safety alerts to relevant recipients.

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

Communicate the revised Buscopan safety recommendations to healthcare professionals through the MHRA Drug Safety Update newsletter.

Verbatim wording from the response

“We have also communicated these new recommendations to healthcare professionals through an article in our MHRA newsletter, Drug Safety Update, which is available at https://www.gov.uk/drug-safety-update”

Source location

2016-0308-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency2
Page 1 · response
Published 26 August 2016

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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

Revise the Buscopan Ampoules Summary of Product Characteristics to strengthen warnings about serious adverse reactions in patients with cardiac disease.

Verbatim wording from the response

“Further to my letter dated 7 December 2016 regarding the inquest into the death of Raymond Charles Woodward, I can confirm that the Summary of Product Characteristics (SmPC) for Buscopan Ampoules has been updated to more clearly communicate and minimise this risk of serious adverse reactions in patients with underlying cardiac disease. Section 4.4 of the SmPC has been revised with the following warning:”

Source location

2016-0308-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency2
Page 1 · response
Published 26 August 2016

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

Analyse reported UK deaths suspected to involve Buscopan Ampoules and review the current product information to determine necessary regulatory action.

Verbatim wording from the response

“To determine what regulatory action, if any, is required with respect to Buscopan Ampoules we have analysed all the reported deaths in the UK that were suspected as being caused by Buscopan Ampoules and reviewed the current product information.”

Source location

2016-0308-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency
Page 1 · response
Published 26 August 2016

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 the Buscopan Ampoules licence holder to revise product information to clarify cardiac risks and recommend monitoring and readily available emergency equipment and trained personnel.

Verbatim wording from the response

“Given that the risk of serious cardiac side effects due to Buscopan Ampoules is more likely in patients with cardiac conditions, such as coronary heart disease, we agree that the product information should be updated to more clearly communicate and minimise this risk in these patients. We have therefore written to the Company who hold the licence for Buscopan Ampoules and requested that they update the product information accordingly. The Company has agreed to revise the warning in section 4.4 of the SmPC which you highlighted as not adequately describing the risk in patients with coronary heart disease. The warning will recommend caution when using Buscopan Ampoules in patients with cardiac disease, including coronary heart disease, because of the risk of tachycardia, hypotension and anaphylaxis.”

Source location

2016-0308-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 26 August 2016

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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