Since Ozempic and Mounjaro are in short supply, pharmacies have produced and supplied commercial quantities of similar diet products.
The Australian government will take action against knock-offs of Ozempic and other weight loss drugs, following reports of hazardous secondary effects including one patient’s hospitalization, shutting a proviso that permitted drug stores to make and sell them to around 20,000 Australians.
Constant shortages throughout the country of brand-name drugs from drug stores – particularly for weight loss, as drug specialists focus on stock for individuals with diabetes – have left patients going to compounding drug stores, which are making their own adaptation of the drugs altogether.
Mark Butler, the federal health minister, said this expanded the risk of security issues and from October, the combination of similar weight loss products or glucagon-like peptide-1 receptor agonists (GLP – 1RA) will be banned.
Most of the 20,000 patients who used a combination of GLP – 1Ras did so for weight loss, Butler said, so the move was not expected to have a major impact on diabetes patients.
“This action will protect Australians from harm and save lives,” Butler said.
Prescription drugs Ozempic (semaglutide) and Mounjaro (tircepatide), approved by the Therapeutic Goods Administration (TGA) for the treatment of type 2 diabetes, have experienced intermittent global shortages.
Self-injectable drugs are also prescribed to treat overweight people and obesity, meaning the TGA has not approved the drugs for these conditions. However, doctors can prescribe diet pills if they believe the patient will benefit from them and it is safe.
Unlike conventional pharmacies, which sell manufactured drugs in packaged strengths and quantities, compounding pharmacies often prepare the prescription from scratch on-site. This is an important service for patients who may be allergic to ingredients in a manufactured product or require a unique dosage.
Children may also need a much lower dose of the adult drug, or patients may need to continue using a drug that is no longer available on the Australian market when an alternative medicine is available. Similar to traditional pharmacies, medicines require a doctor’s prescription.
Because combination drugs are tailored to a specific clinical need and therefore typically produced in small quantities, they are not subject to the same safety requirements as other drug approvals.
However, since Ozempic and Mounjaro are in short supply, pharmacies have produced and supplied commercial quantities of similar diet products. These products are not identical to branded products.
Guardian Australia reported in November that more patients called poison control hotlines and went to emergency departments after taking weight-loss drugs, regardless of whether the drugs were branded or bought online or from pharmacies.
The TGA’s chief medical adviser, Professor Robyn Langham, described it as “the right thing to do”.
She said that the TGA works with key medical, pharmaceutical and consumer stakeholders to support patients and their doctors as they transition and, where necessary, help them find alternative and safer medicines.
The movement of the Australian government is supported by the country’s Therapeutic Goods Administration, while internationally the Food and Drug Administration of the United States has warned about the dangers of injecting some compound products after adverse events in America.