Pharmaceutical company Eli Lilly has filed several lawsuits against certain US medical spas, wellness centers and compounding pharmacies in an attempt to stop them from “the unlawful marketing and sale of non-FDA approved compounded products” which the company says they’re “fraudulently claiming” to be its medication, Mounjaro, which contains the active ingredient tirzepatide.
Lilly filed complaints Tuesday naming businesses in several states.
“Lilly filed this lawsuit to protect patients,” the company said in a statement to CNN Tuesday. “Lilly cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product.”
Mounjaro, which is approved to treat Type 2 diabetes, is manufactured by and commercially available only through Eli Lilly. The company notes that the medications are available only in prefilled single-dose pens.
“These entities should be stopped from providing drug products in violation of consumer protection laws, particularly where they promise their patients that their drugs offer the same safety profile and clinical benefits as Mounjaro,” the statement continues.
Earlier this year, the US Food and Drug Administration issued a warning about some compounded versions of semaglutide, a similar type 2 diabetes drug sold as Ozempic and Rybelsus. Semaglutide is also approved to treat overweight and obesity under the name Wegovy.
In June, the maker of those medications, pharmaceutical firm Novo Nordisk, said it had begun legal proceedings against some US medical spas, weight loss or wellness clinics, and compounding pharmacies “to cease and desist from false advertising, trademark infringement and/or unlawful sales of non-FDA approved compounded products claiming to contain semaglutide.”
The FDA said it had received reports of adverse events in people who used compounded semaglutide and that patients “should not use a compounded drug if an approved drug is available.”
Meanwhile, the FDA has not issued a compounding warning for tirzepatide. However, Mounjaro has been on the FDA’s Drug Shortages list since last year, along with Ozempic and Wegovy.
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“When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act,” the FDA says, but the agency does not review these compounded versions for safety, effectiveness or quality.
Lilly said that compounded versions of tirzepatide can expose users to “potentially serious health risks,” saying “products claiming to contain tirzepatide that are made and/or distributed by compounding pharmacies or distributed by counterfeit sources have not been reviewed by the U.S. FDA or global regulatory agencies for safety, quality, or efficacy.”
CNN’s Katherine Dillinger and Meg Tirrell contributed to this report.
