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Australia’s medicine regulator is investigating several reports of intestinal obstructions in patients using the diabetes turned weight-loss drug Ozempic, in a step that could lead to a change to the drug’s product information.
Ozempic, which has been in short supply since Hollywood stars and influencers boosted its reputation as a quick weight-loss solution, has already been associated with several potential complications, including pancreatitis, diarrhoea, nausea and low blood sugar.
There has been overwhelming demand for Ozempic because of its weight-loss effects.Credit: Richard Gilberto
Gary Wittert, an endocrinologist from the University of Adelaide, said these and other possible side effects should serve as a reminder that Ozempic was a medication “intended to treat serious disease”.
“It’s not meant to be thrown around to lose a few kilograms here or there.”
Last month, the US drug regulator, the Food and Drug Administration (FDA), updated Ozempic’s labelling to recognise that cases of a gastrointestinal disorder called ileus have been reported following use of the drug.
Ileus stops the bowel from working normally to move waste out of the body.
Australia’s Therapeutic Good Administration (TGA) confirmed it had also received three reports of intestinal obstructions and one case of “ileus paralytic”, though a spokesman stressed that there may be no link between these events and the medicine.
The TGA is investigating the issue to see if local updates are required to the drug’s product information.
Prescriptions for Ozempic have exploded in recent years in Australia and around the world, in a trend linked to its growing reputation as a fat-burning drug, and off-label prescribing of the medicine designed as a treatment for type 2 diabetes.
A weight-loss version of the drug, called Wegovy, has not yet been made available in Australia.
Wittert said when Ozempic was properly prescribed for type 2 diabetes, it was a life-saving medication for many people. He said it could also be extremely beneficial for patients whose health and quality of life are being harmed by obesity.
“I use it to treat people with diabetes who have got significant obesity and significant obesity-related comorbidities, and it changes their lives completely. And it’s been extremely frustrating, and sometimes distressing for people, to find that they can’t get it… because it’s being used inappropriately,” he said.
Wittert said Ozempic worked on at least three parts of the body. It works on the gut, slowing gastric emptying, which may help explain cases of ileus.
He said it also works on the pancreas and has been linked to rare cases of pancreatitis. Finally, he said it works on the brain to decrease appetite.
Since 2020, 91 cases of pancreatitis following the use of Ozempic, otherwise known as semaglutide, have been reported to the TGA.
“It is important to note that reporting of an adverse event to the TGA or publication in the DAEN does not necessarily mean that a causal link with the medicine is established,” a TGA spokesman said.
Dr Terri-Lynne South, chair of the obesity management group with the Royal Australian College of General Practitioners, said gastrointestinal side effects such as nausea and vomiting were the most common side effects of Ozempic. Other patients reported constipation or diarrhoea, she said.
South said although the class of drugs that Ozempic belongs to had been around for quite a while, they were still learning about the long-term impacts of Ozempic, which was first developed about a decade ago.
A spokesperson for Novo Nordisk, the company behind Ozempic, said patient safety was a top priority for the company and it worked closely with the FDA and TGA “to continuously monitor the safety profile of our medicines”.
The company said that ileus is a gastrointestinal reaction that was reported post-marketing, and that the Australian product information for Ozempic contained information about gastrointestinal effects.
“Novo Nordisk stands behind the safety and efficacy of Ozempic and all of our medicines when used consistent with the product labelling and the approved indications,” he said.
“For Ozempic, the most commonly reported side effects include: nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.”
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