Australia’s drug regulator is investigating social media platforms and influencers after users started promoting a diabetic drug as a weight-loss treatment.
The Therapeutic Goods Administration (TGA) says the circulation of videos touting Ozempic for weight loss has triggered a surge in demand and contributed to an ongoing worldwide shortage of the drug.
The drug, sold under the brand name Ozempic in Australia, is subsidised under the pharmaceutical benefits scheme (PBS) for the treatment of type 2 diabetes. But doctors also prescribe it “off label” for weight loss in those living with obesity.
The Pharmaceutical Benefits Advisory Committee did not recommend subsidising semaglutide for weight loss when it met in March, stating a lack of longterm data and that it “would require an extremely high investment with very uncertain implications for [the] health budget”.
Under Australian laws, prescription-only medicines cannot be advertised to the public. This is to protect people from false and misleading claims, and to ensure drug information is balanced and accurate.
TikTok influencers have posted videos about their experiences with Ozempic for weight loss, while some media outlets have reported on celebrities using the drug and have carried headlines describing it as a “gamechanger”. These videos and reports often fail to mention potential side-effects or caveats associated with its use.
A TGA spokesperson told the Guardian that it had “received reports of alleged unlawful advertising of Ozempic appearing on digital platforms including social media, websites and through media reporting”.
“When videos about achieving rapid weight loss with Ozempic went viral on TikTok, the trend was also reported online and across other media. This triggered a huge demand for the product that the manufacturer was not prepared for, and it quickly developed into a worldwide shortage.”
The spokesperson added that media organisations promoting Ozempic through positive news stories and headlines “are potentially breaching the Therapeutic Goods Act”.
“The TGA is actively investigating alleged unlawful advertising of Ozempic,” they said. “We are working with several digital platforms including TikTok, Instagram, Facebook, eBay, Amazon and Gumtree among others.”
Advertising to the public can result in criminal penalties of up to $888,000 for individuals and $4.4m for corporations, and civil penalties of up to $1.1m for individuals and $11.1m for organisations.
Ozempic has shown good results for people with obesity in clinical trials funded by the drug’s manufacturer, Novo Nordisk. A separate study published in the journal Diabetes, Obesity and Metabolism found that once patients stop using Ozempic, lost weight is likely to return.
The drug’s use may cause serious side-effects such as possible thyroid tumors including cancer, low blood sugar, and inflammation of the pancreas. The most common side-effects are nausea, diarrhoea and constipation.
Because it is not subsidised by the government, those prescribed Ozempic for weight loss pay roughly $130 per injection pen. It needs to be used alongside lifestyle changes such as diet and exercise.
Countries that have approved the drug for weight loss have guidelines in place. The UK advises it be prescribed for some people living with overweight and obesity provided they meet certain criteria, and that use should not go beyond two years.
It is not possible to resolve shortages by producing semaglutide locally due to a complex manufacturing process using specialised equipment. While another brand of semaglutide, called Wegovy, has been registered on the Australian Register of Therapeutic Goods, the manufacturer has given no indication of when it will be supplied to Australia or how much it will cost.
Diabetes patients who are prescribed Ozempic are being prescribed alternate medicines during the shortage, including Trulicity (dulaglutide). This in turn has resulted in a shortage of Trulicity.
The TGA estimates Ozempic may be available again in April.
Tim Gill, a professor of public health nutrition, said there was reduced availability of semaglutide worldwide.
“As the price that the drug can be sold in Australia is lower than that in other markets, Australia is likely to be a low priority in the supply chain,” he said. “It is a little misleading to attribute supply issues solely to the demand for this drug by those seeking weight loss.”
Obesity charities the Obesity Collective and the Weight Issues Network emphasised people with obesity who have been using Ozempic “have been doing so because their doctor has deemed it clinically important for their healthcare and has prescribed the medication”.
“Obesity is a chronic, relapsing health condition, with many different drivers and causes – including social, genetic, biological, and environmental – and often diet and exercise alone may not be enough for management,” the organisations said in a statement.
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