Source · Prevention of Future Deaths
Mary Nelson
Ref: 2020-0036
Date: 24 Feb 2020
Coroner: Nicholas Shaw
Area: Cumbria
0 responses identified · 1 indexed addressee
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AI-generated concerns summaryThe coroner raised concerns about Fluoxetine accumulating to dangerous levels that could trigger cardiac rhythm disturbance, questioning if dosage guidance needs revision or in-life drug level testing. Additionally, the death was not reported via the Yellow Card system.
Date
24 Feb 2020
56-day deadline
20 Apr 2020
stated in the report
Responses identified
0 of 1
Coroner's concerns
The coroner raised concerns about Fluoxetine accumulating to dangerous levels that could trigger cardiac rhythm disturbance, questioning if dosage guidance needs revision or in-life drug level testing. Additionally, the death was not reported via the Yellow Card system.
View full coroner's concerns
(1) I am concerned that Fluoxetine accumulated in Mary’s body over the course of her treatment reaching a dangerous level that could trigger sudden cardiac rhythm disturbance [?torsades de pointes] and death. Should the guidance for dosage be revised [especially in the elderly], is there any indication to consider in life testing of drug levels? (2)This death has not been reported on the Yellow card system and clearly the MHRA needs to be aware
Fairfield, station Road, Cockermouth, Cumbria CA13 9PT of it. (3)------------------------------
Fairfield, station Road, Cockermouth, Cumbria CA13 9PT
Fairfield, station Road, Cockermouth, Cumbria CA13 9PT of it. (3)------------------------------
Fairfield, station Road, Cockermouth, Cumbria CA13 9PT
Report sections
Investigation and inquest
On 25/09/2019 I commenced an investigation into the death of Mary Nelson. The investigation concluded at the end of the inquest 10th February 2020. The conclusion of the inquest was Mary Nelson died at her home Cumbria on 9th July 2019 due to a combination of hypertensive heart disease and the toxic effect of a properly prescribed medication. Hypertensive Heart Disease and Fluoxetine toxicity
Circumstances of the death
Mary Nelson was a 75 year old lady who had a long history of chronic depression. She had been on a regular prescription of Fluoxetine 60mg daily from her GP since 2009 along with Amitriptyline 10-20mg at night. She rarely attended her GP surgery but did have an ECG suggestive of mild LV hypertrophy and was also on a long term prescription of Bisoprolol 5mg & Ramipril 1.25mg daily and had a previous history of excess alcohol use. The circumstance of her death was simply that she was found deceased on the sofa in her living room when her husband awoke one morning, this appeared to be a sudden death during the night. At post mortem the only significant physical finding was a slightly enlarged heart, coronary arteries were less than 50% occluded by atheroma. Toxicology however revealed a blood Fluoxetine level of 3460ng/ml [lethal range >1300] & Norfluoxetine 1832ng/ml. Amitriptyline however was in therapeutic range. There was no evidence to suggest anything other than that Mary took her regular medication as prescribed. I have discussed this case with the reporting forensic toxicologist. It is acknowledged that Fluoxetine has a large volume of distribution but even allowing for that this is a very high level [and of course lethal ranges are based on PM levels obtained from other cases].
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Report details
- Reference
- 2020-0036
- Date of report
- 24 February 2020
- Coroner
- Nicholas Shaw
- Coroner area
- Cumbria
Responses identified
Responses identified
0 of 1
1 response not yet linked
Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 20 Apr 2020 (stated in the report).
Sent to
- Medicines and Healthcare Products Regulatory Agency