Protect yourself against counterfeit, fake, and unsafe or untested compounded products
The risks of counterfeit and compounded medicine
As a medicine company, we take product safety seriously. We want to make sure you have the information you need to protect yourself against counterfeit, fake, and unsafe or untested compounded knock-offs of Lilly medicines. Unfortunately, a growing number of these products are being mass-marketed and sold online, including through social media. They put people and their health at risk.
What are the risks of counterfeit or fake products?
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Compounded GLP-1 RA versions of registered medicines are not in line with current legislative exemptions for compounding medicines, nor the TGA’s Good Manufacturing Practice licensing processes, which manufacturers of registered products are required to adhere to. Furthermore, compounded products are not subject to the same rigorous safety standards as registered medicines and are subject to safety risks.
How significant of a problem is counterfeiting?
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- Unfortunately, the counterfeiting business is growing. Global criminal networks produce and distribute counterfeits in all major therapeutic areas, in all major geographies and in more than 100 countries. Skirting legal safeguards is big business: counterfeit product sales are estimated to generate between US$200 billion and US$431 billion in illicit proceeds every year.
- Illegal entities are engaging in phishing scams across the internet, phones and social media, claiming to sell weight loss medicines without a prescription. Often, these scammers never deliver anything – they simply pocket your money. Many also steal personal and financial information and use it to commit identity theft later on. Those that do deliver a product don’t provide genuine medications. Instead, people receive fake or counterfeit products, such as an injection pen filled with insulin or saline or some completely unknown product – all of which may pose potentially serious health risks.
How do I know if my medicine is counterfeit or fake?
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- Counterfeit or fake products are mainly promoted and sold over the internet. This is one reason it’s important to obtain a prescription from your doctor and purchase prescription medicine from a pharmacy you are familiar with.
- Counterfeit or fake products may look very similar to genuine Lilly medicines. Knowing what genuine Lilly medicines look like can help you avoid purchasing or using counterfeit products. Contact Lilly Medical Information if you suspect you may have purchased counterfeit or fake product.
What are the risks of compounded products?
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- Compounding is permitted in limited circumstances to address individual patient needs, such as making a medicine without a dye that a patient is allergic to, but it is important to remember that compounded drugs are never evaluated by the TGA.
- According to the United States Obesity Action Coalition, “using a compounded medication is like playing a guessing game with your health. You don’t know what you’re getting, and if something goes wrong, it’s hard to know why.”
- The TGA has identified additional health risks associated with compounding injectable products on a large scale and explained that "[o]nline clinics may also be run by organised crime groups and the products they sell may be fake, ineffective or contain harmful ingredients".
Is there evidence of unsafe or untested compounded products containing GLP-1s?
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- Globally, we have discovered compounded drugs advertised as "tirzepatide" with safety, sterility and efficacy problems. Some have contained bacteria, high impurity levels, different colours (pink, instead of colorless), or a completely different chemical structure than Lilly’s genuine medicines. In at least one instance, the product being offered was nothing more than sugar alcohol.
- On May 21, 2024, the Australian government announced a complete ban on compounded products containing GLP-1s due to the “increasing reports of patients coming to harm from [compounded incretin medications] including the hospitalisation of a patient in Australia due to a serious adverse event.” The ban was introduced in October 2024 and the Minister for Health Mark Butler has continued to voice the Australian Government and TGA’s concern for public safety over compounded products.
- On June 19, 2024, the World Health Organization issued a Medical Product Alert after identifying falsified batches of injectable incretin products in North America, South America and Europe.
- Globally, we have discovered compounded drugs advertised as "tirzepatide" with safety, sterility and efficacy problems. Some have contained bacteria, high impurity levels, different colours (pink, instead of colorless), or a completely different chemical structure than Lilly’s genuine medicines. In at least one instance, the product being offered was nothing more than sugar alcohol.
- On May 21, 2024, the Australian government announced a complete ban on compounded products containing GLP-1s due to the “increasing reports of patients coming to harm from [compounded incretin medications] including the hospitalisation of a patient in Australia due to a serious adverse event.” The ban was introduced in October 2024 and the Minister for Health Mark Butler has continued to voice the Australian Government and TGA’s concern for public safety over compounded products.
- On June 19, 2024, the World Health Organization issued a Medical Product Alert after identifying falsified batches of injectable incretin products in North America, South America and Europe.
Should I believe advertisements about compounded products?
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- It’s important to understand both the risks and benefits of a medication before taking it. That's why prescription medicines are not permitted to be advertised to the general public in Australia. Patients should consult with their healthcare professional for any questions about their care.
- Online ads about compounded products may be inaccurate or misleading. Some online sellers of compounded "tirzepatide" promote the potential health benefits of their products (for example, stating they will lead to easy weight management) without disclosing any potential side effects or safety risks of their products. These same online sellers may also be making claims that their non-injection (e.g., oral, under the tongue, nasal spray) "tirzepatide" products are effective without any scientific research or testing to support those claims.
- Online sellers of compounded "tirzepatide" also sometimes claim that their “tirzepatide” is manufactured in FDA-approved facilities. While the FDA has the authority to approve medications, it does not approve the facilities in which they are manufactured, and FDA regulations expressly prohibit anyone from making that claim precisely because it is “misleading and constitutes misbranding.”
- It’s important to understand both the risks and benefits of a medication before taking it. That's why prescription medicines are not permitted to be advertised to the general public in Australia. Patients should consult with their healthcare professional for any questions about their care.
- Online ads about compounded products may be inaccurate or misleading. Some online sellers of compounded "tirzepatide" promote the potential health benefits of their products (for example, stating they will lead to easy weight management) without disclosing any potential side effects or safety risks of their products. These same online sellers may also be making claims that their non-injection (e.g., oral, under the tongue, nasal spray) "tirzepatide" products are effective without any scientific research or testing to support those claims.
- Online sellers of compounded "tirzepatide" also sometimes claim that their “tirzepatide” is manufactured in FDA-approved facilities. While the FDA has the authority to approve medications, it does not approve the facilities in which they are manufactured, and FDA regulations expressly prohibit anyone from making that claim precisely because it is “misleading and constitutes misbranding.”
What are “research purposes only” products?
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"Research purposes only" products are intended solely for scientific research—they should not be used or promoted for medical purposes. Nonetheless, some entities are promoting “tirzepatide” products for weight loss, even though they are labeled “research purposes only” and “not for human consumption.” These warnings indicate that the products have not been purified to pharmaceutical-grade levels and are not appropriate for human use. You should not use these products. They were not made by, studied by or sold by Lilly and they may expose you to significant health risks.
"Research purposes only" products are intended solely for scientific research—they should not be used or promoted for medical purposes. Nonetheless, some entities are promoting products, even though they are labeled “research purposes only” and “not for human consumption.” These warnings indicate that the products have not been purified to pharmaceutical-grade levels and are not appropriate for human use. You should not use these products. They were not made by, studied by or sold by Lilly and they may expose you to significant health risks.