An Australian mother has died after taking weight loss injectables including Ozempic — which her family claims was prescribed by her doctor — to lose weight for her daughter’s wedding.
“We stand behind the safety and efficacy of Ozempic when used as indicated,” Ozempic manufacturer Novo Nordisk said in a statement to PEOPLE.
Trish Webster, 56, was concerned about fitting into a specific dress for her daughter’s upcoming wedding, her husband Roy told 60 Minutes Australia.
He said Trish saw an ad for Ozempic on TV and reached out to her doctor for a prescription in 2022. But while she was struggling with gastrointestinal side effects like diarrhea, she kept using Ozempic, The Independent reported.
“My daughter was getting married, and she just kept mentioning that dress that she wanted to wear,” he said, according to The Independent. “She went to the dressmaker to get the measurements. It was one big nightmare from there.”
As in the United States, Ozempic is approved in Australia for people with type 2 diabetes — not weight-loss — as the Australian government’s Department of Health and Aged Care noted in September when addressing its shortage.
Ozempic is one of the brand names for semaglutide and tirzepatide — also marketed under the brand name Wegovy, which, unlike Ozempic, is approved for weight-loss management. They work by acting on the brain to impact feelings of satiety, or fullness.
While the Australian agency acknowledged that Ozempic was being prescribed “off-label,” they noted the Australian government “does not have the power to regulate the clinical decisions of health professionals and is unable to prevent doctors from using their clinical judgment to prescribe Ozempic for other health conditions.”
After a few months, Roy said, Trish switched to Saxenda — another injectable — to lose even more weight. Like semaglutide and tirzepatide, the active ingredient in Saxenda — liraglutide — regulates the appetite.
In five months of being on the injectables, Webster reportedly lost 35 lbs. — but the family claims it came with severe side effects like vomiting, diarrhea, and nausea.
And then, on January 16 of this year, Trish Webster stopped breathing.
“She had a little bit of brown stuff coming out of her mouth and I realized she wasn’t breathing, and started doing CPR,” Roy told 60 Minutes Australia.
“It was just pouring out and I turned her onto the side because she couldn’t breathe,” he said.
Webster died that night, with acute gastrointestinal illness being named on her death certificate as the cause.
Roy Webster believes that the weight-loss injectables caused her death, although the official cause of death does not mention the medications.
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“I couldn’t save her; that’s the hard part,” he said. “If I knew that could happen, she wouldn’t have been taking it.”
The impacts of Ozempic and similar medications on the digestive system are currently being investigated; In June, the drugs were linked to severe gastroparesis, also known as stomach paralysis, which the Mayo Clinic says “[prevents] your stomach from emptying properly.”
And in September, the FDA issued a warning that Ozempic can lead to a life-threatening condition known as ileus—a type of bowel obstruction where either sections or the entirety of the intestines become obstructed. This blockage can restrict blood flow to organs, resulting in tissue necrosis.
A spokesperson for Ozempic’s manufacturer, Danish firm Novo Nordisk, told PEOPLE in a statement,
“Patient safety is a top priority for Novo Nordisk. We take all reports about adverse events from use of our medicines very seriously. However, we do not comment on individual patient cases.”
The statement continued: “Ozempic (semaglutide) is a prescription medicine that should be taken under the care of a licensed healthcare provider. Ozempic is FDA-approved for the treatment of type 2 diabetes, to improve blood sugar, along with diet and exercise, and reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease. Ozempic is not indicated for chronic weight management.”
Regarding gastrointestinal effects, Novo Nordisk told PEOPLE in its statement that “The safety and efficacy profile of Ozempic has been evaluated in clinical studies involving more than patients. The most commonly reported side effects were gastrointestinal, including nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation. The known risks associated with use of Ozempic are reflected in the FDA-approved product labeling.”
“We stand behind the safety and efficacy of Ozempic® when used as indicated,” Novo Nordisk said.