Pharmaceutical company Eli Lilly has taken legal action against various medical spas, wellness centers, and compounding pharmacies in the United States. The company aims to prevent the unlawful marketing and sale of non-FDA approved compounded products that are falsely claimed to be their medication, Mounjaro, containing the active ingredient tirzepatide.
Eli Lilly filed complaints on Tuesday against businesses located in multiple states. The company states that it has initiated legal proceedings in order to protect patients. Eli Lilly emphasizes that it cannot guarantee the safety or effectiveness of products claiming to contain tirzepatide that are not their own branded product. Mounjaro, approved for treating Type 2 diabetes, is exclusively manufactured by Eli Lilly and is only available in prefilled single-dose pens.
Eli Lilly argues that these entities should be stopped from providing drug products in violation of consumer protection laws, especially when they falsely promise the same safety profile and clinical benefits as Mounjaro.
Earlier this year, the US Food and Drug Administration (FDA) issued a warning regarding some compounded versions of semaglutide, a similar drug used to treat Type 2 diabetes. The pharmaceutical company Novo Nordisk, the maker of semaglutide medications, subsequently initiated legal proceedings against medical spas, weight loss or wellness clinics, and compounding pharmacies that engage in false advertising, trademark infringement, or the unlawful sale of non-FDA approved compounded products claiming to contain semaglutide.
The FDA has received reports of adverse events associated with the use of compounded semaglutide and advises patients to only use approved drugs. While the FDA has not issued a compounding warning for tirzepatide, Mounjaro has been on the FDA’s Drug Shortages list since last year, along with other medications such as Ozempic and Wegovy.
The FDA allows compounders to prepare a compounded version of a drug that is in shortage, as long as certain requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act are met. However, the FDA does not review these compounded versions for safety, effectiveness, or quality. Eli Lilly warns that compounded versions of tirzepatide can pose potentially serious health risks since they have not undergone review by the FDA or other regulatory agencies.