Tirzepatide has arrived in Australia, along with sketchy websites claiming to sell the drug without a prescription.
The TGA has urged Aussies to dob in illegal online sellers of prescription medicines like tirzepatide and semaglutide even though offshore providers may be out of legal reach.
A spokesperson for the regulator told Rheumatology Republic it was “aware of websites targeting consumers seeking access to medications for the treatment of type 2 diabetes and off-label for weight loss”.
“Consumers are strongly advised not to use products unless they have come from a trusted source,” he said.
The news came as the first new class of type 2 diabetes medicines in almost a decade was made available in Australia. While the self-injectable tirzepatide (Mounjaro, Eli Lilly) has TGA approval for type 2 diabetes, it has so far failed to achieve PBS listing.
The company has not provided a price guide for the private prescription, telling Rheumatology Republic in a statement the retail price “will be determined by the pharmacy and may vary subject to pharmacy and dispensing fees”.
Rheumatology Republic has searched for the drug at legitimate online pharmacies in Australia and was unable to find available stock of the drug or a retail price, but hears anecdotally from multiple sources that it can be obtained.
While tirzepatide is not approved in Australia for weight loss alone, research showing its efficacy in that area is tipped to result in Australians seeking it out on private prescription in similar fashion to the hugely popular semaglutide (Ozempic, Novo Nordisk).
And with the Australian shortage of semaglutide expected to last throughout 2024, the appetite for off-label tirzepatide could skyrocket.
Last week Rheumatology Republic accessed an online service which promised to send cold-packed supplies of tirzepatide without a prescription to Sydney. All that was required was a bank transfer or PayPal payment and the supplier claimed it would ship the medication.
Tirzepatide is a schedule 4 medication that requires an Australian prescription.
Prices ranged from $200 for a month’s supply of 2.5mg injectors to $1299 for a five-month supply of 12.5mg injectors. Refrigerated and cold shipping added $39 to the overall cost.
The website, mounjaroaustralia.com, includes images of the branded pre-filled syringe pens. It also has information about the drug, although disturbingly there were discrepancies between the advice given and the legitimate product information provided by Eli Lilly.
“During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor,” the website states.
“Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).”
This directly contradicts the advice in the Australian product information, which says tirzepatide should not be used during pregnancy as there are “no adequate and well-controlled studies of tirzepatide in pregnant women”.
“Women of childbearing potential are advised to use contraception during treatment with tirzepatide (see Section 4.5 Interactions with other medicines and other forms of interactions),” the PI says. “If a patient wishes to become pregnant or becomes pregnant, treatment with tirzepatide should be discontinued.”
The website makes no claim to be affiliated with the drug company.
When Rheumatology Republic attempted to purchase the product, the Australian bank declined to transfer the money to the website’s WISE account, saying it looked “suspicious”. In subsequent communications with the sellers, which took place in the early hours of the morning, a seemingly personal PayPal account was offered to direct the money instead. The use of a WISE account, a popular method of international money transfer, the time of messages and the use of FedEx suggest this is an offshore operation.
A spokesperson for Eli Lilly Australia said the company was aware of the website but would not make a comment.
The TGA spokesman said advertising prescription tirzepatide to the public was prohibited.
“Appropriate treatment options involving prescription medicines should only be determined between a treating medical professional and their patient in consultation, rather than on the basis of commercial advertising.”
He said if consumers saw Mounjaro products being advertised online, or where they were supplied without the need for a prescription, “this is a clear warning that the advertisement could be a scam”.
“The TGA can and does take action in relation to illegal advertising of health products, including in relation to online advertising,” he said.
“It is important to note however that overseas advertising is likely to be outside of the TGA’s jurisdiction.”
The spokesman warned unlawful advertising of a prescription medicine in Australia could result in jail time and penalties of up to $1.565 million for individuals and $15.65 million for corporations.
“The public is encouraged to report illegal or questionable practices to the TGA,” he told Rheumatology Republic.
“Consumers should not access medicines from unknown sources, noting that the TGA cannot guarantee the quality, safety or efficacy of the product. Additionally, the use of any prescription medicine for an unapproved use, especially in the absence of medical supervision, carries significant risks. This is particularly the case since rare side effects, or delayed effects, may not be apparent early in treatment.”
