An inquest in Cork has been told that a 66-year old woman died from "profound vomiting" brought on by the drug Ozempic, which she had been prescribed to help her lose weight.
Breeda O'Donoghue, of West End, Carrigtwohill, Co Cork, died of total organ failure in December 2023 at Cork University Hospital, where she had been admitted following daily episodes of vomiting for weeks.
The inquest at Cork City Coroner's Court heard that the reaction Ms O'Donoghue suffered was caused - on the balance of probabilities - by Ozempic, as she had only been on the drug for three months, while another drug she had been on for more than six years to treat type two diabetes had caused her no ill effects.
Vomiting was a known side affect of both drugs, the inquest was told.
Ms O'Donoghue was a mother of two and a grandmother of eight and, according to her family, she enjoyed good health until around six weeks before she died.
She had been diagnosed with type two diabetes and a number of other conditions and was seen regularly by her GP in Carrigtwohill.
The inquest was told she was prescribed metformin to treat her type two diabetes in 2016 and had not suffered side effects. She was also on a number of other medications to treat other conditions.
In September 2023, concerned about her weight, she was prescribed a low dose of Ozempic with the dose increasing progressively to 1mg on 26 October.
At all stages, she reported to her GP that she was tolerating the medication well and she denied any problems.
She was reviewed a month later in November and reported nausea.
She was still suffering nausea a week later and was advised by her GP to stop taking Ozempic, but she wasn't keen to attend the surgery for review and said she would attend at a later date if she didn't improve.
On 6 December, her husband Paudie rang the GP surgery and said Ms O'Donoghue was unwell. She was weak and dehydrated and was brought to the emergency department at Cork University Hospital by ambulance.
At the ED, she reported that, since she started taking Ozempic, she had experienced multiple episodes of vomiting every day and she was unable to keep food down.
She was transferred from the emergency department to the intensive care unit, where she continued to deteriorate and she died on 9 December.
Organ failure due to abnormalities ruled as cause of death
At the inquest into her death, a report from the Health Products' Regulatory Authority was read which detailed a number of adverse reactions to Ozempic. The report said nausea and diarrhea were very common side effects of the drug.
Pathologist Dr Margot Bolster carried out an autopsy on Ms O'Donoghue's body. She told the inquest that death had been caused by total organ failure, due to profound electrolyte abnormalities.
She described Ms O'Donoghue's death as a very complex case, which was multifactorial.
She said when somebody is vomiting regularly, that changed the pH level or acidity of their cells and the cells won't function properly, leading to total organ failure.
She said that is what had happened in Ms O'Donoghue's case.
Dr Bolster said every drug carried risks as well as benefits.
"It is always risk versus benefit," she said.
Coroner Philip Comyn said Ms O'Donoghue had a history of vomiting, which was a recognised side effect of both Ozempic and Metformin.
He pointed out that she had been on Metformin since 2016, with no ill effects.
'No lab in the world' willing to measure Ozempic levels
Dr Bolster agreed that while Metformin couldn't be ruled out as a contributory factor to the vomiting Ms O'Donoghue had suffered, it was "less likely", given that she had been on the drug for so long without suffering adverse side effects.
Dr Bolster said that as part of her post mortem examination, she sought to have tests done to quantify the level of Ozempic in Ms O'Donoghue's blood system, but "no lab in the world" was offering to measure levels of Ozempic in the blood system because it was such a new drug.
She said that was something that would have to be looked at.
Dr Bolster said that while there were various media reports, she couldn't find any scientific literature published to date on death from Ozempic.
Mr Comyn said death was a result of a known side effect of a prescribed medication, against a background of a complex medical history.
As they left the inquest, members of Ms O'Donoghue's family said they wanted greater awareness of the side effects of Ozempic.
