Med spas, wellness centers and online sellers were recently hit with lawsuits by Eli Lilly and Company for providing “unapproved compounded” versions of drugs used for diabetes management and weight loss.
Eli Lilly announced Thursday that it published an open letter about counterfeit, fake and compounded versions of its tirzepatide medications. Last April, Audacy reported that experts believed that one of those medications known as Mounjaro – originally approved for use as a diabetes medication – could be the next major weight loss drug. Ozempic, another diabetes drug, has become known for causing weight loss.
Another version of the drug from Eli Lilly is called Zepbound. Both Mounjaro and Zepbound are not intended for cosmetic weight loss and they are approved for people age 18 and older.
According to the U.S. Food and Drug Administration, “drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient,” and it includes combining two or more medications. This practice is not FDA-approved.
In its legal actions, Eli Lilly alleged that defendants have misleadingly referred to their products as Mounjaro or Zepbound or something similar to those medications. It also alleged that the defendants referred to Eli Lilly’s clinical trials in advertising and misleadingly referenced FDA approvals.
“Lilly also identifies significant dangers to patient safety associated with the defendants’ products and their deceptive conduct,” said the company press release.
Many of these products can be found online, on social media and through med spas. They “may contain no medicine, the wrong medicine, incorrect dosages, or multiple medicines mixed together, which could result in serious harm,” Eli Lilly explained. Other issues related to compounded drugs advertised as tirzepatide include safety, sterility, and efficacy problems.
“Some have contained bacteria, high impurity levels, different colors (pink, instead of colorless), or a completely different chemical structure than Lilly’s FDA-approved medicines. In at least one instance, the product was nothing more than sugar alcohol,” said the company.
One red flag indicating counterfeit tirzepatide is the advertisement of pill or oral versions of the medication. So far, the FDA has only approved under-the-skin injection of the drug.
Previously, Eli Lilly filed lawsuits last September and October to ensure patient safety. This May, the company entered into a settlement agreement with Totality Medispa in South Carolina. That agreement required the spa to make a payment and prohibited it from engaging in conduct that misled consumers. Eli Lilly has entered into similar settlements with other establishments.
“Eli Lilly and Company is committed to meeting the needs of people living with diabetes and obesity with treatment options that change the way healthcare providers can treat these diseases,” said the company.