Australia to ban replicas of weight loss drugs Ozempic and Mounjaro

“You only have to look to the recent reports of individuals impacted by large-scale compounding to realise the dangers posed. This action will protect Australians from harm and save lives.”

Compounding has become a big business for online telehealth start-ups, such as the Woolworths-backed Eucalyptus and NIB’s Midnight Health, which use digital doctors’ consults to prescribe the drugs.

The practice has been resisted by the manufacturers – multibillion-dollar international pharmaceutical giants Novo Nordisk and Eli Lilly – whose profits have soared in the past two years.

Ozempic and Mounjaro were designed for diabetes but company trials soon showed patients lost up to 15 per cent of their body weight, leading share prices to skyrocket and sparking headlines about them revolutionising the future of obesity.

Ozempic is subsidised at $31.60 in Australia for type 2 diabetes but is frequently purchased “off-label” – meaning a purpose for which the drug has not been approved – for weight loss at a higher price, starting from $130 a month depending on the dosage. Mounjaro hit Australian shelves last year but is not subsidised by the government. The TGA says shortages of both are expected to continue.

The much-hyped drugs come with side effects: the most common are nausea, diarrhoea, constipation and dehydration, although the US Food and Drug Administration is also probing the risk of more serious side effects including hair loss and suicidal ideation.

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The federal government said stopping the large-scale manufacture of compounded injections had broad support from the health sector, including general practitioners, the Medical Board of Australia, Diabetes Australia, the Eating Disorders Alliance of Australia and state and territory health departments.

Companies compounding the drugs could not be contacted because the government’s decision was not public, but they have previously argued their actions help make important medicines available to Australians who would otherwise be worse off.

“Without the medication and without the ongoing lifestyle changes that we are trying to do for these patients, the overwhelming data says that those patients will put the weight back on,” Eucalyptus chief executive Tim Doyle has said.

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“In the situation where they put their weight back on, all of the health risks that come with that increase in likelihood.”

But the Therapeutic Goods Administration’s chief medical adviser, Professor Robyn Langham, said banning compounded weight loss drugs was the right action.

“The TGA will work with key medical, pharmacy and consumer stakeholders to support patients and their practitioners to navigate the change, and where appropriate help with guidance in finding alternative and safe medicines,” she said.