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
(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’.