Source · Prevention of Future Deaths

Mary Nelson

Ref: 2020-0036 Date: 24 Feb 2020 Coroner: Nicholas Shaw Area: Cumbria Responses identified: 0 / 1 View PDF

Dangerous fluoxetine accumulation suggests a need to revise dosage guidance, especially for the elderly, and consider in-life drug testing. This death was also not reported to the Yellow Card system.

Date 24 Feb 2020
56-day deadline 20 Apr 2020
Responses identified 0 of 1
Alcohol, drug and medication related deaths

Coroner's concerns

AI summary
Dangerous fluoxetine accumulation suggests a need to revise dosage guidance, especially for the elderly, and consider in-life drug testing. This death was also not reported to the Yellow Card system.
View full coroner's concerns
[BRIEF SUMMARY OF MATTERS OF CONCERN] (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

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.

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Medicines and Healthcare Products Regulatory Agency

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