The Therapeutic Goods Administration (TGA) advises consumers that 'retatrutide' products marketed for weight loss may pose a serious risk to your health and should not be used.
The TGA has received a report of a serious adverse effect linked to a product sold as retatrutide. The consumer experienced uncontrollable vomiting, resulting in a torn oesophagus, and required treatment in hospital.
During its investigation, the TGA obtained a sample of the product contained in its original unmarked vial. TGA laboratory testing of the product found that:
- the product contained undeclared semaglutide and no retatrutide.
- the amount of semaglutide detected was approximately 8 times higher than the level found in semaglutide products assessed by the TGA and included in the Australian Register of Therapeutic Goods.
Retatrutide is currently undergoing clinical trials in humans and has not been approved by the TGA or any comparable international regulator. Any retatrutide product accessed outside of clinical trials could be a counterfeit product. It should not be used outside a clinical trial setting.
Consumers are urged not to use unapproved peptide products, particularly those supplied in unmarked vials, purchased online or obtained from overseas.
Products being sold online may be fake or counterfeit and could contain undisclosed or incorrectly dosed ingredients that pose serious risks to health. Consumers should seek advice from qualified healthcare professionals and use only products supplied through Australian pharmacies.
Professor Robyn Langham AM, the TGA’s Chief Medical Adviser, said “The biggest risks with unapproved peptide products are not knowing what is in the vial, how much of or even what substance it contains, whether it is sterile, or whether it contains other contaminants or toxins.
"These risks are particularly concerning for injectable products, where contaminated or non-sterile manufacturing can increase the risk of infection and harmful immune responses including anaphylaxis. People who self-inject these products also face additional risks, including incorrect dosing, unsafe injection technique and serious adverse reactions."
Professor Anthony Lawler, Deputy Secretary of the Department of Health, Disability and Ageing and head of the TGA, said this safety alert highlights the importance of only using products approved for supply in Australia.
"Consumers must understand that the safety of these imported products is not assessed by the TGA. They are not subject to the same controls over the quality or efficacy of the goods when compared with medicines approved for supply in Australia," Professor Lawler said.
The TGA has published a number of safety alerts relating to unapproved peptide products on the TGA website, including a national warning from the Chief Medical Officer.
Action we are taking
The supply and advertising of unapproved therapeutic goods in Australia is prohibited unless a relevant exemption applies. Consequences for non-compliance may include infringement notices, direction or prevention notices, or civil or criminal penalties.
Our investigation and compliance activities identify therapeutic goods that compromise the health and safety of consumers. Our investigations attempt to locate the source or supply of this material and work with the parties involved to remove the products form the market.
Consequences for non-compliance may include infringement notices, direction or prevention notices, or civil or criminal penalties. Penalties that can be imposed for breaches of the Act include civil penalties of up to $1.82 million per breach for individuals or $18.2 million per breach for corporations, and criminal penalties of up to 7 years imprisonment.
For more information on the types of actions we may take in instances of substantiated non-compliance, please see the Compliance and enforcement hub on the TGA website.
Reporting problems
If you experience an adverse event, please report it to the TGA. This helps us to monitor and respond to emerging safety concerns.
If you suspect non-compliance in relation to therapeutic goods, you can report a perceived breach or questionable practice to the TGA.
| Phone: | 1800 020 653 |
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| Email: | info@tga.gov.au |