Australia’s medicines regulator has warned about the dangers of unapproved injectable peptides after a patient suffered a torn oesophagus while using a product labelled as retatrutide. The Therapeutic Goods Administration said the patient experienced uncontrollable vomiting and required hospital treatment.
Laboratory testing found the vial contained no retatrutide, but instead contained undeclared semaglutide, the active drug used in Ozempic and Wegovy. The TGA said the amount detected was approximately eight times higher than levels in semaglutide products it had assessed.
Retatrutide is undergoing human clinical trials and has not been approved by the TGA or any comparable international regulator. The regulator said it should not be used outside a clinical trial setting.
Melbourne gastroenterologist Darcy Holt told ABC News that a torn oesophagus was a medical emergency. He said forceful vomiting caused by a high dose of a drug could produce the injury, allowing stomach contents to enter an area near the heart and major blood vessels and causing serious infection and inflammation.
The warning followed testing by ABC News and the University of Queensland, which found that black-market products labelled as retatrutide contained doses substantially higher than those stated on their labels. Holt said he had also treated patients who experienced other adverse effects after using unapproved counterfeit peptides, including liver toxicity and severe diarrhoea.
TGA chief medical adviser Robyn Langham said the risks included not knowing what substance was in a vial, the quantity present, whether it was sterile or whether it contained contaminants or toxins. She said those risks were especially concerning for injectable products because contamination or non-sterile manufacturing could lead to infection or serious immune reactions, including anaphylaxis.