Patient suffers torn oesophagus after using unapproved peptide product

The patient bought a fake weight loss product thought to be retatrutide.

After using the product they experienced uncontrolled vomiting that resulted in a torn oesophagus requiring hospital treatment.

The product was later tested by the Therapeutic Goods Administration (TGA) and was found to contain no retatrutide. Instead, it contained semaglutide at levels eight times higher than the level found in semaglutide products assessed by the TGA.

The product was not advertised as containing semaglutide.

The case has promoted a fresh warning from the medicines regulator about unapproved peptide products and the serious risk they pose to health.

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 and should not be used outside a clinical trial setting.

TGA Chief Medical Advisor Professor Robyn Langham warned there was no way of knowing what these products contained.

“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.”

A spate of adverse events including liver toxicity, severe allergic reactions, inflammation and other health complications requiring medical attention have been linked to unregulated peptides.

Cases of liver toxicity linked have been linked to retatrutide.

The TGA has been cracking down on unregulated peptides for a number of months as they have gained popularity online.

The increasing use of the products has also prompted the Medical Board of Australia to work with the TGA and Ahpra on developing guidelines for prescribing peptides.

The Board has been investigating unsafe prescribing and compounding practices, alongside Ahpra.

“Some consumers are sourcing illicit substances directly online, without adequate health advice,” the Board said in a recent newsletter.

“Others are sourcing them from registered practitioners who are not meeting their professional responsibility to only prescribe peptides when there is a clinical need and evidence to support the treatment.

“We’re concerned that high consumer demand for peptides is leading some practitioners to side-step their professional responsibilities. By putting profits ahead of patients, these practitioners are putting public safety at risk and could face regulatory action.”

Health practitioners can report an adverse event or safety problem here.

Or report counterfeit or unregulated products here.