Patient suffers torn oesophagus after counterfeit peptide use

A patient has been hospitalised with a torn oesophagus after using a fake weight-loss peptide sold as retatrutide.
 
Testing found the product contained undeclared semaglutide and not retatrutide as advertised, with the amount of semaglutide detected being eight times higher than the level found in products in the Australian Register of Therapeutic Goods.
 
After using the unapproved product, the patient suffered uncontrolled vomiting and was hospitalised.
 
Dr Terri-Lynne South, Chair of RACGP Specific Interests Obesity, said this latest case has left her concerned that previous warnings are not being heard by patients.
 
‘It shows that people don’t really know what they’re getting, and you can’t be guaranteed that you get what you think you’re getting,’ she told newsGP.
 
‘Particularly in this case, the excessive dose is really worrisome from a safety point of view.
 
‘When I hear these stories it’s very alarming because typically, it’s the sort of patients that are not necessarily seeking this for health reasons, it seems to be driven by other reasons that are beyond the TGA indications for these medications.’
 
On Monday, the Therapeutic Goods Administration (TGA) released the latest in a string of urgent warnings against the use of such peptides, saying retatrutide is currently undergoing clinical trials in humans and has not been approved.
 
It says any retatrutide product accessed outside of clinical trials could be a counterfeit product and 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.

‘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,’ said Professor Robyn Langham, TGA Chief Medical Advisor.

‘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.’

Despite numerous warnings from the TGA and healthcare experts, illegal peptide use continues to skyrocket across Australia, spurred on by social media influencers’ promises of miracle weight loss or muscle growth.
 
With the peptide trend showing no sign of slowing down, Dr South said GPs play a critical role in informing and protecting their patients.
 
‘We need to approach it like we do with any medications that are not prescribed, so specifically asking, “do you take anything over the counter or complementary?”,’ she said.
 
‘You can start off with more questions and see how people respond, then that would lead to opening the conversation when the patient feels that there isn’t going to be any judgement or shame.
 
‘It can be that open-ended question that allows that patient to feel comfortable and talk about not just these concerning illegal peptides, but other potential complementary medicine supplements that doctors should know about as well.’
 
In response to the growing peptide boom, the TGA said current investigations are attempting to locate their source and remove the products from the market.
 
Head of the TGA Professor Anthony Lawler said this latest 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,’ he said.
 
‘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.’
 
In June, the watchdog formally expanded its priority focus areas to include unapproved peptide products, reflecting its ‘scaling up of regulatory attention’.

Anyone who suspects non-compliance in relation to therapeutic goods can report a perceived breach or questionable practice to the TGA.
 
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