Raymond Woodward

PFD Report All Responded Ref: 2016-wp25391
Date of Report 26 August 2016
Coroner Emma Brown
Response Deadline ✓ from report 14 October 2016
All 2 responses received · Deadline: 14 Oct 2016
Coroner's Concerns (AI summary)
The risk of adverse cardiovascular reactions to Buscopan, especially in patients with ischaemic heart disease, is not widely known, and the Summary of Product Characteristics (SPC) for intravenous Buscopan could be more specific regarding this risk.
View full coroner's concerns
(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.

(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. (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'.
Responses
Medicines and Healthcare Products Regulatory Agency2 Other
1 Mar 2017
Action Taken
The Summary of Product Characteristics (SmPC) for Buscopan Ampoules has been updated to more clearly communicate and minimise the risk of serious adverse reactions in patients with underlying cardiac disease. These recommendations have also been communicated to healthcare professionals through an article in the MHRA newsletter, Drug Safety Update. (AI summary)
View full response
Dear Miss Brown

RE: RAYMOND CHARLES WOODWARD, DECEASED, date of death 19/02/16 (Ref: 113062)

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:

Buscopan Ampoules can cause tachycardia, hypotension and anaphylaxis, therefore use with caution in patients with cardiac conditions such as cardiac failure, coronary heart disease, cardiac arrhythmia or hypertension, and in cardiac surgery. Monitoring of these patients is advised. Emergency equipment and personnel trained in its use must be readily available.

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
Medicines and Healthcare Products Regulatory Agency Other
Response received (text not yet extracted)
Sent To
  • Medicines and Healthcare Products Regulatory Agency
Response Status
Linked responses 2 of 1
56-Day Deadline 14 Oct 2016
All responses received
About PFD responses

Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.

Source: Courts and Tribunals Judiciary

Report Sections
Investigation and Inquest
On 31/05/2016 I commenced an investigation into the death of Raymond Charles Woodward. The investigation concluded at the end of the inquest on the 18th August 2016. The conclusion of the inquest was: "Death during a routine medical investigation as a result of a reaction to medication given in conjunction with previously undiagnosed coronary artery disease."
Circumstances of the Death
The Deceased passed away in the accident and emergency department of the Queen Elizabeth Hospital, Birmingham on the 19th February 2016 having suffered a cardiac arrest whilst undergoing a colonoscopy for the investigation of abdominal pain, dyspepsia and constipation at the Edgbaston BMI Hospital. The colonoscopy had been proceeding normally when the Deceased suddenly deteriorated after the administration of Buscopan to reduce spasm. Despite comprehensive cardio-pulmonary resuscitation he did not regain circulation. He was transferred to the Queen Elizabeth Hospital to maximise treatment if resuscitation were achieved but was declared deceased at 18.10. Following a post mortem examination and toxicological analysis the Cause of Death was determined as: 1(a) CARDIORESPIRATORY ARREST 1(b) CORONARY ARTERY DISEASE AND A REACTION TO ADMINISTERED BUSCOPAN Evidence was provided to me there have been 5 reported instances of adverse reactions to Buscopan in the presence of coronary artery disease resulting in death. It is reasonable to suppose that there could be more unreported instances. CORONER'S CONCERNS During the course of my investigation and the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows. (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. (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. (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'.
Action Should Be Taken
This opinion was fully supported by who lead Mr. Woodward's resuscitation. and also Consultant Cardiac Anaesthetist 8
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.