A 58-year-old Scottish nurse died after taking two doses of the weight-loss drug Mounjaro, recently approved by the United Kingdom’s National Health Service (NHS), BBC reported.
Susan McGowan’s death certificate lists multiple organ failure, septic shock and pancreatitis as the immediate cause of death. However, the “use of prescribed tirzepatide,” the generic name for Mounjaro, is listed as a contributing factor.
It is thought to be the first death in the U.K. officially linked to the injectable drug, also sold under the brand name Zepbound. Eli Lilly manufactures the drug.
McGowan, who worked as a nurse for more than 30 years at University Hospital Monklands in Airdrie, North Lanarkshire, had struggled with weight loss. After the drug was approved she sought medical advice and purchased a prescription from an online pharmacy, according to the BBC.
The drug costs 150-200 pounds ($191-$255) for a four-week supply and can be bought from any registered pharmacy in the U.K. In the U.S., the drug costs about $1,060 per month.
McGowan took two doses of the drug over about two weeks. Days after her second injection, she began experiencing severe illness and was admitted to the hospital where she worked.
Her family was informed that her kidneys weren’t working. She soon went into a coma, then organ failure and subsequently died.
An Eli Lilly spokesperson told the BBC that patient safety is its top priority. “We are committed to continually monitoring, evaluating and reporting safety information for all Lilly medicines,” they said.
“Mounjaro was approved based on extensive assessment of the benefits and risks of the medicine, and we provide information about the benefits and risks of all our medicines to regulators around the world to ensure the latest information is available for prescribers,” they added.
Serious side effects reported in the U.S. and UK
Tirzepatide is one of several new blockbuster weight loss drugs that work by making people feel full so they eat less. It belongs to the GLP-1 receptor agonist class of drugs, which also includes Novo Nordisk’s Ozempic and Wegovy.
The drugs were originally developed to treat diabetes but were also found to be effective for weight loss. They are taken via weekly self-administered injections.
The drugs have different names depending on whether they’re prescribed for weight loss or to treat diabetes. The names also vary by country.
For example in the U.S., tirzepatide is approved as Mounjaro for diabetes and Zepbound for weight loss. Semaglutide is approved as Ozempic for diabetes and Wegovy for weight loss. But the active drug is identical, and the diabetes versions are also commonly prescribed off-label for weight loss.
Since the U.S. Food and Drug Administration (FDA) approved Wegovy in 2021, the drug — and the entire class of drugs — has become a sensation. Celebrities and social media influencers routinely share before-and-after pictures on Instagram and TikTok, helping to fuel a massive new drug market estimated to be worth $100 billion a year for drugmakers.
However, the GLP-1 receptor agonists come with serious side effects, ranging from vomiting, diarrhea and nausea, to pancreatitis, stomach paralysis, kidney disease and thyroid cancer.
The drugs pose such serious risks to pregnant women that doctors have argued they should carry a black box warning. They’ve also been linked to suicidal ideation.
In clinical trials, about 80% to 90% of participants experienced at least one adverse event. Though most were mild to moderate, the reactions led some people to discontinue the medication, Mercola reported.
The drugs are intended for long-term use — stopping them often results in weight regain, further increasing the risk of side effects over time.
The FDA approved Zepbound for weight loss in November 2023. The UK Medicines and Healthcare products Regulatory Agency (MHRA) also approved the drug, under the name Mounjaro, for weight loss in the U.K. for adults in November 2023.
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Two months after its approval, Lilly launched a direct-to-consumer sales platform called LillyDirect.
LillyDirect allows patients to access the medicines by filling out a form on the website. They are connected to independent health providers, which the company says “can complement a patient’s current doctor or be an alternative to in-patient care in some cases,” WebMD reported.
According to data from the FDA’s Adverse Event Reporting System (FAERS), the GLP-1 drugs have been linked to 162 deaths in the U.S., the Daily Mail reported.
As of September, FAERS had recorded 62,000 reactions to weight loss drugs containing semaglutide and tirzepatide, including Ozempic and Mounjaro, since 2018.
In the U.K., safety data is reported in the MHRA’s Yellow Card scheme, where anyone can report suspected side effects. The BBC reported that between January and May 2024, there were 208 reports on tirzepatide, including 31 serious reactions and one death in addition to McGowan’s.
For Wegovy and Ozempic, Yellow Card shows reports of 23 deaths since 2019.
The MHRA chief safety office spokesperson Alison Cave, Ph.D., told the BBC: “Patient safety is our top priority and no medicine would be approved unless it met our expected standards of safety, quality and effectiveness. We have robust, safety monitoring and surveillance systems in place for all healthcare products.”
She added, “On the basis of the current evidence the benefits of GLP-1 RAs [receptor agonists] outweigh the potential risks when used for the licensed indications.”
The organization offered its “sincere sympathies” to McGowan’s family.
The U.K. government recently announced plans to roll out Mounjaro for unemployed people to help them get back to work. The government is partnering with Lilly to run a five-year study involving up to 3,000 people. The study will measure the effect of the drug on “worklessness.”
The NHS also pointed to other possible benefits for work productivity, saying obese people on average take four extra sick days per year.
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GLP-1 receptor agonists recommended for kids in the U.S.
The FDA in December 2022 approved Wegovy for children ages 12 and up.
Just weeks later, in January 2023, the American Academy of Pediatrics issued new guidelines on childhood obesity — the first update to the guidelines in 15 years — recommending weight loss drugs for obese children as young as 8 and consultation for bariatric surgery for children with severe obesity as young as 13.
There are no long-term studies on the effects of the drugs in adults or teens.
Novo Nordisk is also running clinical trials for another GLP-1 drug, liraglutide, in children ages 6 to 11. In September, the drugmaker reported positive late clinical trial results in the New England Journal of Medicine.
Pediatric endocrinologist Dr. Roy Kim told NBC News there were concerns that giving these drugs to children could cause serious pancreas problems, thyroid cancer risk and damage to bone health over a lifetime.
“We do not know the long-term effectiveness and safety of these medicines in children,” Kim said.
A group of researchers at the University of California, Irvine, also raised concerns over the dearth of research on the long-term effects of the drugs.
Children, they wrote, need energy for physical activity, like adults. But they also need extra energy from their diet for growth and development. Any change in the balance of caloric intake and energy expenditure, which the drugs may easily cause, could adversely affect children’s health later in life.
They warned against the increasing “medicalization of pediatric conditions.”