A 66-YEAR-OLD woman died of total organ failure after she developed profound electrolyte abnormalities on a background of severe vomiting whilst taking Ozempic for weight loss and Metformin to control her diabetes, an inquest in Cork has heard.

Breeda O’Donoghue of West End in Carrigtwohill, Co Cork died on 9 December, 2023 at Cork University Hospital (CUH) having been hospitalised three days earlier. A family member told Cork Coroner’s Court that Breeda 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 in to the record Dr Ranga said that the deceased was a diagnosed Type two diabetic. Breeda also had osetoathritis, restless legs and hypertension.

Dr Ranga said that Mrs O’Donoghue had commenced on 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 that Mrs O’Donoghue was struggling to lose weight via diet in exercise and was “very self conscious.”

Dr Ranga said that in 2023 Mrs O’Donoghue, who was 5ft 3 inches in height, had a BMI of 35.94. Dr Ranga said that Breeda was 92KG.

“She was reviewed and had blood tests and her diabetes was controlled, but she was unable to lose weight. So per protocol, she was started on Ozempic 0.25mg on 19/09/23 and after four weeks the dose was increased to 0.5mg on 19/10/23.

She was reviewed on 26/10/23 and her weight had reduced to 85.7kg (13 stone and 6.94 pounds) and her BMI was now 33.4. She was very happy and managing well and denied any problems.”

Dr Ranga said that on 26 October, 2023 the dose of Ozempic was increased to 1.0mg.

“She (Mrs O’Donoghue) was again reviewed on 07/11/23 and was very happy with the results, denying any problems and said that she was tolerating the medication well.

On 23/11/23, she 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.

But she was not keen to attend, so she stated that she would attend at a later date if she did not improve.

Her husband rang on 06/12/23 reporting that she was not well, so I 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 that Mrs O’Donoghue has been using Metformin since 2016 and reported “no issues.”

The inquest heard that the patient died at lunchtime on the 9th of December 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 that she had been “unable to keep anything down” and that her condition had worsened prior to her hospitalisation. Mrs O’Donoghue said that 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 Professor Joseph Eustace, Consultant Nephroloist at CUH was also read in to the record.

Professor Eustace said that in his clinical opinion the proximate 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.”

Professor Eustace said that Ozempic associated euglycemic ketoacidosis and a urinary tract infection were possible “contributing features” in the case.

He said that 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 (Ozempic.)

Professor 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 that 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 that 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 that 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 stated that the GP of the deceased had followed the correct protocols in terms of prescribing and monitoring Ozempic with the patient. Mr Comyn said that Mrs O’Donoghue’s diabetes had been controlled and she had been managing it well herself.

He stated that the pensioner had gone on Ozempic to lose weight as opposed to treating her diabetes.

Mr Comyn said that 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 blood of the deceased 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 indicated that 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 that 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. Mr Comyn said that their attendance spoke volumes about the deceased. Sgt Twomey stated that the passing of the much loved mother and grandmother was “tragic.”