The World Health Organization (WHO) has issued a medical product alert on falsified semaglutides, the type of medicines that are used for treatment of type 2 diabetes and obesity in some countries. Meanwhile, Eli Lilly and Company has warned patients about counterfeit and compounded medicines for type 2 diabetes and obesity.
The WHO alert addresses three falsified batches of product of semaglutide class of medicines (of specific brand Ozempic), which have been detected in Brazil in October 2023, the United Kingdom of Great Britain and Northern Ireland in October 2023, and the United States of America in December 2023. WHO Global Surveillance and Monitoring System (GSMS) has been observing increased reports on falsified semaglutide products in all geographical regions since 2022. This is the first official notice issued by WHO after confirmation of some of the reports.
“WHO advises healthcare professionals, regulatory authorities and the public be aware of these falsified batches of medicines,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “We call on stakeholders to stop any usage of suspicious medicines and report to relevant authorities.”
WHO has been observing increased demand for these medicines as well as reports on falsification. These falsified products could have harmful effects to people’s health; if the products don’t have the necessary raw components, falsified medicines can lead to health complications resulting from unmanaged blood glucose levels or weight. In other cases, another undeclared active ingredient may be contained in the injection device, e.g. insulin, leading to an unpredictable range of health risks or complications.
Semaglutides are not part of WHO-recommended treatments for diabetes management due to their current high cost. The cost barrier makes these products unsuitable for a public health approach, which aims to ensure the widest possible access to medicines at the population level and to strike a balance between the best-established standard of care and what is feasible on a large scale in resource-limited settings. Also, there are more affordable treatments available for diabetes, with similar effects to those of semaglutides on blood sugar and cardiovascular risk.
WHO is currently working on a rapid advice guideline on possible use of GLP-1 RAs, including semaglutides, for treatment of obesity in adults and as part of a more comprehensive model of care. The term GLP-1 RAs stands for glucagon-like peptide-1 receptor agonists, which include semaglutides, for a class of medicines used for diabetes treatment to lower blood sugar and support weight loss.
To protect themselves from falsified medicines and their harmful effects, patients who are using these products can take actions such as buying medicines with prescriptions from licensed physicians and avoid buying medicines from unfamiliar or unverified sources, such as those that may be found online. People should always check packaging and expiry dates of medicines when they buy them and use the products as prescribed.
Separately, Eli Lilly has published an open letter to ensure that people living with diabetes and obesity, their families, and their healthcare providers are informed about potentially serious risks posed by the proliferation of counterfeit, fake, compounded, and other unsafe or untested versions of its FDA-approved tirzepatide medications (Mounjaro and Zepbound) and about appropriate use of our authentic medicines.
As part of this effort, Lilly is filing several legal actions against med-spas, wellness centres and other entities selling unapproved compounded products containing what they claim is tirzepatide.
In these actions, Lilly alleges that the defendants: (1) misleadingly refer to their products as Mounjaro/Zepbound or the same as Mounjaro/Zepbound (2) misleadingly refer to the results of Lilly’s clinical trials in their advertising, deceiving consumers to believe the defendants’ compounded drugs were part of Lilly’s clinical trials; and (3) misleadingly refer to the FDA approvals for Mounjaro/Zepbound as if defendants’ compounded drugs were themselves FDA-approved. Lilly also identifies significant dangers to patient safety associated with the defendants’ products and their deceptive conduct.
Lilly’s open letter addresses appropriate uses of its medications and explains that counterfeit products and unsafe or untested compounded tirzepatide put people at risk.
Lilly is concerned by the proliferation of fake or counterfeit products that are advertised or designed to look like Lilly’s genuine FDA-approved Mounjaro and Zepbound medications. These products are often advertised and sold online, through social media, or at certain med-spas. They may contain no medicine, the wrong medicine, incorrect dosages, or multiple medicines mixed together, which could result in serious harm. They are never safe to use, the company warns.
The National Association of Boards of Pharmacy has explained that “illegal actors are taking advantage of high demand and short supply [of incretin medications] in order to sell substandard and falsified versions of these products to patients around the world.” Their “unlawful actions put patients at risk.”
Compounded products may be legal in limited circumstances to address specific patient needs, but they are not FDA-approved and lack the same safety, quality, and efficacy protections as FDA-approved medicines. FDA has explained: “compounded drugs pose a higher risk to patients than FDA-approved drugs,” and that the “unnecessary use of compounded drugs exposes patients to potentially serious health risks.”
Lilly has discovered compounded drugs advertised as tirzepatide with safety, sterility, and efficacy problems. Some have contained bacteria, high impurity levels, different colours (pink, instead of colourless) or a completely different chemical structure than Lilly’s FDA-approved medicines. In at least one instance, the product was nothing more than sugar alcohol.
Certain online pharmacies are now advertising compounded pill or other oral versions of “tirzepatide.” FDA has only approved administration of tirzepatide via under-the-skin injection. No regulator has evaluated the safety or effectiveness of pill or oral versions of “tirzepatide.”
Lilly also reiterates that Mounjaro and Zepbound are approved only for use by adults to treat serious diseases, they are not intended for cosmetic weight loss or use by people under 18.
The lawsuits follow a series of cases Lilly filed in September and October 2023 as part of its commitment to ensure patient safety.
In May 2024, Lilly entered into a settlement agreement with Totality Medispa that required Totality to make a monetary payment and prohibited it from engaging in certain conduct that misled consumers into believing that it sells Lilly’s Mounjaro® or Zepbound or an FDA-approved alternative. It has entered into similar settlements with other med-spas and wellness centres who previously had infringed Lilly’s trademarks and falsely advertised the med-spas’ products.