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Legal Action Being Taken Over Compounded Versions of Mounjaro

Medically reviewed by Drugs.com.

By Physician’s Briefing Staff HealthDay Reporter

WEDNESDAY, Sept. 20, 2023 -- Another diabetes drug maker is taking legal action against businesses in several states, alleging that they are "fraudulently claiming" that their compounded products are the same as its medication.

This time, it is Eli Lilly suing certain medical spas, wellness centers, and compounding pharmacies over its medication Mounjaro. The medication contains the active ingredient tirzepatide and is approved by the U.S. Food and Drug Administration to treat type 2 diabetes. The company sells Mounjaro only in prefilled single-dose pens.

The lawsuits, filed Tuesday, are meant to stop the other companies from "the unlawful marketing and sale of non-FDA approved compounded products." In a statement issued Tuesday, the company said: "Lilly cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product. 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."

In June, Novo Nordisk sued businesses for making compounded versions of semaglutide, which is used in its type 2 diabetes drugs Ozempic and Rybelsus. The medication is also used to treat obesity under the brand name Wegovy. In its cases, Novo Nordisk has asked the companies to "cease and desist from false advertising, trademark infringement, and/or unlawful sales of non-FDA approved compounded products claiming to contain semaglutide."

Eli Lilly said these compounded versions can cause "potentially serious health risks," adding that "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."

People have reported adverse events from compounded semaglutide, according to the FDA. The agency has said patients "should not use a compounded drug if an approved drug is available." However, Mounjaro has been on the agency's drug shortages list since last year, along with Ozempic and Wegovy. "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 said.

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© 2024 HealthDay. All rights reserved.

Posted September 2023

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