Mary Nelson · Prevention of Future Deaths report

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

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].

[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 of it.
(3)--------------------------