Topline
Several medical spas and wellness centers are facing potential lawsuits from drugmaker Eli Lilly for allegedly selling compounded and counterfeit versions of ultra-popular weight loss and diabetes drugs Mounjaro and Zepbound, a problem also raised by Ozempic maker Novo Nordisk—and health organizations warn these products may pose serious side effects like infections.
Key Facts
Eli Lilly, the maker of Mounjaro and Zepbound, warned of the dangers of counterfeit drugs in an open letter Thursday, stating people should never use drugs labeled "research purposes only" or "not for human consumption,” and noting federal regulators haven’t approved oral versions of either drug even though pills have appeared online in some cases.
The company says some wellness centers and websites are selling unauthorized and counterfeit versions of these weight loss and diabetes drugs made with unapproved chemicals and sold as generic versions, including compounded versions with mixed or changed ingredients, though Lilly has said it doesn’t sell generic versions of its drugs.
It also warned these fake versions of its products are harmful because they may contain incorrect dosage, the wrong medication, no medication at all or several medications mixed together, which could result in “serious harm” and are never safe to use.
Products with fake tirzepatide—the generic name for Mounjaro and Zepbound—have been found to contain bacteria, high impurity levels and different chemicals from Lilly’s real drugs, and some have had safety, efficacy and sterility issues, according to the letter.
Tirzepatide isn’t the only diabetes and weight loss drug to face counterfeiting: The Food and Drug Administration warned consumers in December to not use counterfeit semaglutide—the generic name for Ozempic and Wegovy—sold by unauthorized online retailers due to the potential for adverse events like infection and abdominal pain.
As of March 31, the FDA has received over 100 adverse event reports from counterfeit tirzepatide and semaglutide products since 2020, including several life-threatening cases, 19 hospitalizations and at least two deaths, though the source of the complaints is unclear.
Key Background
The National Association of Boards of Pharmacy said earlier this year “illegal actors are taking advantage of high demand and short supply in order to sell substandard and falsified versions of these products to patients around the world, which in turn puts “patients at risk.” Several doses of Wegovy, Ozempic, Zepbound and Mounjaro have been in a shortage for months due to high demand. Lilly has warned that besides being sold in medical clinics, fake versions of its products are being sold online and on social media. The company said it doesn’t sell genuine Zepbound and Mounjaro on social media.
Tangent
In Lilly’s open letter Thursday, it also stated it was seeking legal action against several medspas, wellness centers and other clinics that sell unapproved compounded and counterfeit versions of its products. Lilly alleges these clinics misleadingly refer to the fake products as Mounjaro and Zepbound, misleadingly use Lilly’s clinical trial results to sell their products and deceptively use the FDA’s approval of Lilly’s drugs to sell the fake products. Lilly previously filed similar lawsuits in September and October 2023, and settled with one company—South Carolina-based Totality Medispa—in May. As part of the deal, Totality Medispa agreed to pay an undisclosed amount of money, only distribute compounded tirzepatide products that are “produced in compliance with U.S. federal law” and report all adverse events to the FDA. Novo Nordisk recently filed lawsuits against nine wellness clinics in May for selling compounded versions of its Ozempic and Wegovy. The company claims some of these products contained up to 24% impure chemicals. Novo Nordisk is requesting the companies stop marketing and selling their products claiming to contain semaglutide, in addition to compensation of up to $75,000.