Health
What to know if Eli Lilly plans lawsuits against Mounjaro, Zepbound counterfeiters
Topline
What to know if Eli Lilly plans lawsuits against Mounjaro, Zepbound counterfeiters, Several medical spas and wellness centers are facing potential lawsuits from drugmaker Eli Lilly for allegedly selling compounded and counterfeit versions of the ultra-popular weight loss and diabetes drugs Mounjaro and Zepbound, an issue also being addressed by Ozempic maker Novo Nordisk – and health organizations warn these products can cause serious side effects, such as infections.
A woman holds an injectable Mounjaro pen.
The Washington Post via Getty Images
Key facts
Eli Lilly, the maker of Mounjaro and Zepbound, warned about the dangers of counterfeit drugs in a open letter On Thursday, it declared that people should never use drugs labeled “for research purposes only” or “not for human consumption,” and that federal regulators have not 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 medications, made with unapproved chemicals and sold as generic versions, including composed versions with mixed or modified ingredients, although Lilly has done so said it does not sell generic versions of its drugs.
The company also warned that these counterfeit versions of its products are harmful because they may contain the incorrect dosage, the wrong medications, no medications at all, or multiple medications mixed together, which could lead to “serious harm” and are never safe to use.
Products containing fake tirzepatide — the generic name for Mounjaro and Zepbound — have been found to contain bacteria, high impurity levels and different chemicals than Lilly’s real drugs, and some have 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 not to use counterfeit semaglutide – the generic name for Ozempic and Wegovy – sold by unauthorized online retailers due to the potential for side effects such as infection and abdominal pain.
As of March 31, the FDA has received more than 100 adverse reactions reports of counterfeit tirzepatide and semaglutide products since 2020, including several life-threatening cases, 19 hospitalizations and at least two deaths, although the source of the complaints is unclear.
How do you know if your weight loss medications are fake?
There are several ways to spot fake GLP-1 drugs. Lilly noted that some knock-off versions of its products have a pink tint instead of being colorless like the official products. If the product is labeled as generic tirzepatide or semaglutide, it is fake because neither Lilly nor Novo Nordisk sells generic versions of their medications. Another way to recognize a counterfeit is incorrect dosage. If the medications are listed as something other than the official tirzepatide or semaglutide dosage, then the medicines are fake. Counterfeit boxes may also contain grammatical errors, a lack of tamper-resistant perforation, and the batch number on the counterfeit box may not match the product strength listed on the same box and pen.
Important background
The National Association of Boards of Pharmacy said earlier this year, “illegal actors are taking advantage of high demand and short supply to sell substandard and counterfeit versions of these products to patients around the world, which in turn is “putting patients at risk.” There has been a shortage of various doses of Wegovy, Ozempic, Zepbound and Mounjaro for months due to high demand. Lilly has warned that in addition to sales in medical clinics, counterfeit versions of its products are also sold online and on social media. The company said it does not sell genuine Zepbound and Mounjaro on social media.
Tangent
At Lilly’s open letter On Thursday, it also said it was seeking legal action against several drug spas, wellness centers and other clinics that sell unapproved compounded and counterfeit versions of its products. Lilly claims that these clinics misleadingly refer to the counterfeit products as Mounjaro and Zepbound, misleadingly use the results of Lilly’s clinical trials to sell their products, and deceptively use the FDA’s approval of Lilly’s drugs to sell the counterfeit products to sell. Lilly has previously made a similar request lawsuits in September and October 2023, and organized with one company – South Carolina-based Totality Medispa – in May. As part of the deal, Totality Medispa agreed to pay an undisclosed amount, distribute only compounded tirzepatide products “manufactured in accordance with U.S. federal law,” and report all adverse events to the FDA. Novo Nordisk recently filed lawsuits in May against nine wellness clinics for selling compounded versions of its Ozempic and Wegovy. The company claims that some of these products contain up to 24% impure chemicals. Novo Nordisk is asking the companies to stop marketing and selling their products claiming to contain semaglutide, in addition to compensation of up to $75,000.
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