A woman died of total organ failure after she developed profound electrolyte abnormalities from vomiting while taking Ozempic for weight loss and Metformin to control her diabetes, an inquest in Cork has heard.
Breeda O’Donoghue (66), of West End in Carrigtwohill, Co Cork, died on December 9th, 2023, at Cork University Hospital (CUH) after being admitted to hospital three days earlier.
A family member told Cork Coroner’s Court that Mrs O’Donoghue was “fine” and in “good health” until she took Ozempic in a bid to lose weight.
Coroner Philip Comyn heard that Mrs O’Donoghue joined the surgery of Dr Sushil Ranga in Carrigtwohill in early 2017 after she moved to the area.
In a report read into the record, Dr Ranga said Mrs O’Donoghue was a diagnosed type-two diabetic. She also had osteoathritis, restless legs and hypertension.
Dr Ranga said Mrs O’Donoghue had started taking diabetes drug Metformin after she was prescribed it by her GP in Youghal in 2016.
“She was seen on a regular basis and monitored along with blood test, etc. Her diabetes was very well controlled at this point on medication and diet so she did not require endocrinology.”
In 2020 Mrs O’Donoghue had a flare up of her osteoarthritis. Over time her pain settled but she started to gain weight.
Dr Ranga said Mrs O’Donoghue was struggling to lose weight via diet and exercise.
The doctor said that in 2023 Mrs O’Donoghue had blood tests and her diabetes was controlled, but she was unable to lose weight. She was then prescribed Ozempic, initially on a 0.25mg dose and after four weeks the dose was increased to 0.5mg.
Mrs O'Donoghue lost some weight and the doctor said she "was very happy and managing well and denied any problems."
Dr Ranga said on October 26th, 2023, the dose of Ozempic was increased to 1.0mg.
Mrs O’Donoghue was reviewed on November 7th and was "very happy with the results, denying any problems and said that she was tolerating the medication well," the doctor's report said.
On November 23rd, Mrs O'Donoghue reported nausea only, but was drinking plenty fluids and was eating ok, so she was prescribed anti-nausea medication and advised to review after a week. After one week, she was still suffering from nausea, so she was advised to stop Ozempic and review.
Dr Ranga said Mrs O'Donoghue was not keen to attend, so she said that she would attend at a later date if she did not improve.
Mrs O'Donoghue's husband rang Dr Ranga on December 6th, 2023, reporting that she was not well. Dr Ranga "immediately reviewed her in clinic. On examination she was feeling weak, dehydrated and was generally unwell, so she was immediately sent to A and E via ambulance for further hospital management.”
Dr Ranga said Mrs O’Donoghue has been using Metformin since 2016 and reported “no issues.”
The inquest heard that Mrs O'Donoghue died at lunchtime on December 9th, 2023, at CUH after various treatments failed to improve her condition.
When she presented at hospital she told the registrar that she had “multiple episodes of vomiting every day” having started on Ozempic three months earlier.
She said she had been “unable to keep anything down” and her condition had worsened prior to her hospitalisation. Mrs O’Donoghue said she has been due to get a further injection three days before she went to hospital but she hadn’t taken it.
The inquest was told that on arrival at CUH Breeda was “volume depleted and hypotensive.”
Meanwhile, a report from Prof Joseph Eustace, a consultant nephroloist at CUH, was also read into the record.
Prof Eustace said in his clinical opinion the cause of death on the case was “hypovolemic acute kidney injury associated with use of Ozempic, an angiotensin receptor blocker (Losartin) and non steroidal agents and with a resultant severe Metformin induced lactic acidosis.”
Prof Eustace said that Ozempic associated euglycemic ketoacidosis and a urinary tract infection were possible “contributing features” in the case.
He said Mrs O’Donoghue presented to the hospital with a “complex combination of severe metabolic abnormalities” having been vomiting “on a frequent basis” over the last two to three months since starting treatment with semaglutide, also known as Ozempic.
Prof Eustace described “gastrointestinal side effects” as a “well recognised” problem of semaglutide.
The inquest also heard that assistant State pathologist Dr Margaret Bolster carried out a postmortem examination on Mrs O’Donoghue.
She said she tried in vain to get a laboratory to test levels of Ozempic in the blood of Mrs O’Donoghue, having checked both in Ireland and internationally.
“We can’t do levels of Ozempic [in the blood]. No lab in the world could do the levels of Ozempic for me.
Dr Bolster said she would to like to see such testing carried out. She described what had happened to Mrs O’Dongohue as “very rare.”
She said that whilst she had read newspaper reports about deaths which were possibly linked to Ozempic there was no “scientific literature on mortality rates of this drug.”
Dr Bolster said that as the drug is being prescribed more widely for weight loss the scientific literature will follow in relation to its usage.
Dr Bolster said that as data is collected it will be possible to establish “what if any are the mortality rate of these drugs.”
She said the use of Metformin was “less likely” to have been an issue in the case but she was unable to rule it out. Dr Bolster added that the benefits of both drugs were “well recognised” but that every drug given to a patient comes with a risk factor.
She noted that “gastro intestinal issues” were a “known side effect” of Ozempic. Dr Bolster said that it was a “complex, multi factorial case.”
She said that the PH level in Mrs O’Donoghue’s blood changed due to profound vomiting impacting her cell activity and leading to total organ failure.
The cause of death was given as “total organ failure due to profound electrolyte abnormalities with a mixed high anion gap metabolic acidosis with lactic acidosis, hypochloraemia on Ozempic and Metformin.”
Coroner Philip Comyn said that the situation at the inquest was similar to that of a recent Covid vaccine inquest where there was a similar “lack of scientific data” on relatively new drugs.
“The literature and scientific studies are not in place yet because Ozempic is a new drug on the market, so it will be some time before we can have a more considered review of Ozempic.
Dr Bolster tried to get tests carried out to ascertain the level of Ozempic in the blood. The State Laboratory didn’t have the facilities.”
He said Mrs O'Donoghue's doctor had followed the correct protocols in terms of prescribing and monitoring Ozempic with the patient. Mr Comyn said Mrs O’Donoghue’s diabetes had been controlled and she had been managing it well herself.
He said the pensioner had used on Ozempic to lose weight as opposed to treating her diabetes.
Mr Comyn said one of the possible side effects of Ozempic is “nausea and excess vomiting.” He noted that Dr Bolster had been unable to get a test of the Ozempic levels in the blood of Mrs O'Donoghue amid extensive efforts.
Mr Comyn said he was unaware if such testing is available now and expressed his belief that it is something that should be available going forward.
He said he had been in touch with the HPRA in relation to the inquest and would advise them of the details of the case.
He said Mrs O’Donoghue had died of a “known complication of a prescribed medication.” He indicated that the death of Mrs O'Donoghue had involved a “complex medical history.”
It was emphasised that Mrs O’Donoghue and her doctors followed all the correct protocols and procedures in relation to Ozempic.
However, in a general point Mr Comyn expressed concern about members of the public sourcing Ozempic outside of the GP setting. Dr Bolster agreed that such practices by members of the public were dangerous in nature.
Mr Comyn and Sgt Fergus Twomey offered their heartfelt condolences to the members of the O’Donoghue family who were present in court in large numbers.
The coroner said the family's attendance spoke volumes about Mrs O'Donoghue. Sgt Twomey said the death of the much loved mother and grandmother was “tragic.”
