Copycat Ozempic to be banned in Australia
Copycat versions of Ozempic and other weight loss jabs will be banned. This is what it means for Aussie users.
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Compounding chemists will be banned from making replica versions of diabetes and weight loss medications Ozempic and Mounjaro as serious side effects emerge.
More than 20,000 Australians are believed to be using the copycat products produced by compounding chemists in the back rooms of their shops.
The burgeoning market has been spurred by a worldwide shortage of the real medications.
Announcing the crackdown Health Minister Mark Butler said he was “really concerned in the way in which this market has developed that compromises public safety”.
“This action will protect Australians from harm and save lives,” he said.
Doctors raised the alarm after one patient experienced tingling in their feet and toes after using compounded products that were found to contain high doses of vitamin B6 and B12.
Another person had severe vomiting and diarrhoea.
Mr Butler said one patient had been hospitalised after a serious adverse event after using a compounded version of the drug.
Professor Robyn Langham the Chief Medical Adviser to the Therapeutic Goods Administration backed the ban as “the right action to take”.
Compounding chemists are allowed to make one off products for a single individual but some have engaged in full on commercial scale production of compounded versions of Ozempic and Mounjaro.
Some Aussie compounding chemists are exporting the product overseas as well as marketing it online in Australia and have been advertising it to general practitioners.
The medicines watchdog the TGA does not test compounded products and there are major concerns about their safety.
Compounding chemists can use chemical ingredients to mix up treatments in their own pharmacies but it is only legal for them to make drugs that appear on a government list.
The ban will work by removing the chemicals in Ozempic and Mounjaro- glucagon-like peptide-1 receptor agonists (GLP-1RA)- from the list of permitted compounding products.
The change will take effect from 1 October 2024, to allow patients time to consult with their doctor and find alternative treatments.
The government said the ban had the support of the Royal Australian College of General Practitioners, the Medical Board of Australia, the Pharmacy Board of Australia, Diabetes Australia, the Eating Disorders Alliance of Australia, as well as all state and territory health departments.
“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,” Professor Langham said.
“While I understand that this action may concern some people, the risk of not acting is far greater,” Mr Butler said.
“You only have to look to the recent reports of individual impacted by large-scale compounding to realise the dangers posed,” he said.
Compounding chemists who defy the ban will face civil and criminal penalties under the Therapeutic Goods Act 1989.
Medical practitioners and pharmacists who continue to use or produce compounded products could be referred to the medical regulator the Australian Health Practitioner Regulation Agency (Ahpra).
Ahpra can impose restrictions on their ability to practice or ban them from working in their field altogether.
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Originally published as Copycat Ozempic to be banned in Australia
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