Diabetes drug maker sues over compounded Mounjaro versions.

Diabetes drug maker sues over compounded Mounjaro versions.

Eli Lilly Takes Legal Action Against Businesses Making False Claims About Diabetes Medication

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Eli Lilly, a prominent diabetes drug maker, has taken legal action against various businesses in multiple states for falsely claiming that their compounded products are equal to Eli Lilly’s medication, Mounjaro. The lawsuits are primarily aimed at medical spas, wellness centers, and compounding pharmacies. Mounjaro, approved by the U.S. Food and Drug Administration (FDA) for the treatment of type 2 diabetes, contains the active ingredient tirzepatide. In an effort to prevent the unauthorized marketing and sale of non-FDA approved compounded products, Eli Lilly filed the lawsuits on Tuesday.

The lawsuit’s goal is to protect patients, as Eli Lilly cannot guarantee the safety or effectiveness of products claiming to contain tirzepatide that are not their own branded product. Mounjaro is exclusively sold by Eli Lilly in prefilled single-dose pens. The company’s statement emphasizes the importance of preventing entities from violating consumer protection laws by providing drug products that promise the same safety profile and clinical benefits as Mounjaro.

This legal action by Eli Lilly follows a similar case initiated by Novo Nordisk in June. Novo Nordisk sued companies for manufacturing compounded versions of semaglutide, which is used in their type 2 diabetes drugs Ozempic and Rybelsus, as well as for the treatment of obesity under the brand name Wegovy. Novo Nordisk demanded that these businesses cease false advertising, trademark infringement, and the sale of non-FDA approved compounded products claiming to contain semaglutide. Eli Lilly’s stance aligns with Novo Nordisk’s concerns, as they argue that these compounded versions can pose potentially serious health risks.

Eli Lilly highlights that products claiming to contain tirzepatide and are manufactured and/or distributed by compounding pharmacies or counterfeit sources have not undergone safety, quality, or efficacy reviews by the FDA or global regulatory agencies. The FDA has received reports of adverse events resulting from compounded semaglutide and advises patients to avoid using compounded drugs when approved alternatives are available.

Interestingly, Mounjaro, along with Novo Nordisk’s Ozempic and Wegovy, has been included in the FDA’s drug shortages list since last year. According to the FDA, during a drug shortage, compounders may be permitted to prepare a compounded version of the drug if they meet specific requirements outlined in the Federal Food, Drug, and Cosmetic (FD&C) Act.

In conclusion, Eli Lilly’s legal action against businesses falsely claiming that their compounded products are equivalent to Mounjaro reinforces their commitment to patient safety. It also underscores the importance of FDA approval and regulation in ensuring the safety, quality, and efficacy of diabetes medications. Patients are advised to consult with their healthcare providers and use approved medications rather than compounded drugs to avoid potential risks.