Pharmaceuticals

Lilly Warns of Fake Weight-loss Drugs

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Lilly Warns of Significant Risks from Counterfeit and Compounded Medicines

Eli Lilly and Company, a global leader in pharmaceuticals, has issued a stark warning about the dangers of counterfeit and compounded medicines claiming to be their FDA-approved tirzepatide products, Mounjaro® and Zepbound®. In an open letter, Lilly highlights the serious risks posed by these fake, unsafe, and untested medications, emphasizing the critical need for patients and healthcare providers to be vigilant and informed.

The Growing Threat of Counterfeit and Compounded Medications

Lilly’s commitment to patient safety is underscored by their recent actions against entities selling unapproved compounded products purporting to be tirzepatide. These products are often misleadingly marketed to resemble Lilly’s genuine medications, creating significant risks for patients. The counterfeit products, which are frequently sold online, through social media, or at med-spas, may contain no medicine, the wrong medicine, incorrect dosages, or a mix of multiple medicines. This not only renders them ineffective but also poses serious health risks.

Legal Actions to Protect Patients

In response to this growing threat, Lilly is taking legal action against med-spas, wellness centers, and other entities that are misleadingly marketing their products. The lawsuits allege that these entities:

Misleadingly refer to their products as Mounjaro®/Zepbound® or equivalent to these FDA-approved medications.
Use results from Lilly’s clinical trials in their advertising, deceiving consumers into believing that their compounded drugs were part of Lilly’s trials.
Misleadingly refer to the FDA approvals for Mounjaro®/Zepbound® as if their compounded drugs were also FDA-approved.

These deceptive practices not only violate trademarks but also endanger patient safety by promoting unapproved and potentially harmful products.

The Dangers Highlighted by Lilly

Lilly’s open letter and accompanying legal actions highlight several critical risks associated with counterfeit and compounded tirzepatide products:

Safety and Quality Concerns: Compounded products often lack the rigorous safety, quality, and efficacy standards of FDA-approved medicines. The FDA has stated that compounded drugs pose a higher risk to patients, exposing them to potentially serious health issues.
Contamination and Incorrect Formulations: Some of the discovered compounded drugs have been found to contain bacteria, high impurity levels, incorrect colors, or completely different chemical structures than Lilly’s authentic medications. In extreme cases, these products contained nothing more than sugar alcohol.
Improper Administration Forms: Certain online pharmacies have begun advertising oral versions of tirzepatide, despite the FDA only approving its administration via under-the-skin injection. No regulatory body has evaluated the safety or effectiveness of these oral versions.
Inappropriate Uses: Mounjaro® and Zepbound® are approved for treating serious diseases in adults and are not intended for cosmetic weight loss or use by individuals under 18.

Previous Legal Successes

Lilly’s recent lawsuits build on earlier legal successes in combating the proliferation of counterfeit medicines. In May 2024, Lilly settled with Totality Medispa, which required the spa to make a monetary payment and prohibited it from misleading consumers about selling Lilly’s products. Similar settlements have been reached with other med-spas and wellness centers that infringed Lilly’s trademarks and falsely advertised their products.

The Importance of Patient Awareness

Lilly’s open letter serves as a crucial reminder of the importance of using only FDA-approved medications. The proliferation of counterfeit and compounded medicines poses a significant risk to patient health, and it is essential for patients and healthcare providers to be aware of these dangers and take steps to ensure they are using authentic products.

Conclusion

Eli Lilly’s proactive measures to warn patients and take legal action against counterfeit and compounded medicine sellers underscore the company’s dedication to patient safety. By highlighting the risks and taking decisive action, Lilly aims to protect patients and ensure they receive the highest quality and safest treatments available. For more information, patients and healthcare providers are encouraged to read the complete open letter from Lilly.