On 16 June 2022 I commenced an investigation into the death of Susan Elizabeth SKILLEN aged 61. The investigation concluded at the end of the inquest on 16 November 2022. The conclusion of the inquest was that: Susan Skillen was a 61 year old lady who had a number of co-morbidities including interstitial lung disease and a history of rheumatoid arthritis, for which she was prescribed methotrexate and leflunomide. Susan had recently been on holiday to Turkey where she developed pain to her upper back with large area skin redness and peeling skin. Her skin was treated, there appeared to be no signs of infection but as a precautionary measure, antibiotics were prescribed. On 26 May 2022 Susan was admitted to Arrowe Park Hospital after being found on the bedroom floor at her home address. She said she had slipped from the bed and found it very hard to stand but she was noted to have reduced consciousness. Susan was found to have low blood pressure and hypoglycaemia, with laboratory investigations showing severe neutropenia (low neutrophils - a type of white blood cell that fights infection). Despite medical treatment, she continued to deteriorate and died later the same day, 26 May 2022. The post mortem examination found Susan died as a result of neutropenic sepsis. As mentioned, Susan had a history of rheumatoid arthritis, for which she was prescribed methotrexate and leflunomide; these suppress the inflammatory response triggered by disease. Neutropenia and neutropenic sepsis are recognised but rare complications of these drugs. No other source of infection was seen either at post mortem examination or following histological assessment, however, it is more likely than not this area of skin loss over her back was the most likely source of infection. Phototoxicity is a condition that looks and feels like severe sunburn. It is a type of photosensitivity that occurs when a chemical (often a drug ingested or topically applied) combines with the UV light leading to skin damage in the region of sun exposure. Methotrexate has been associated with phototoxicity and from the evidence it is more likely than not the phototoxicity has likely contributed to the development of the area of skin loss over the back. Overall, it is more likely than not Susan died as a result of the inadvertent extremely rare consequences/side effects of the combined effects of sun exposure and medication to treat rheumatoid arthritis.

5 CORONER’S CONCERNS During the course of the investigation my inquiries revealed matters giving rise to concern. In my opinion there is a risk that future deaths could occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows: (brief summary of matters of concern) Phototoxicity is an extremely rare side effect of methotrexate but does not appear in literature given to patients. The hospital were requested to complete the Yellow Card system but it was unclear if the literature for patients needed to be reviewed depending upon how many other patients had suffered this side effect.