In breaking news last week, Eli Lilly is preparing to sue several medical spas and wellness centers for allegedly selling counterfeit and compounded versions of its popular weight loss and diabetes drugs, Mounjaro and Zepbound. This issue has also been raised by Novo Nordisk, the maker of Ozempic, and health organizations, who warn that these fake products can cause serious side effects, including infections.
In an open letter on Thursday, Eli Lilly cautioned against using drugs labeled “research purposes only” or “not for human consumption,” highlighting that federal regulators have not approved oral versions of Mounjaro or Zepbound, despite some pills appearing online.
The counterfeit drugs are said to be unsafe
The company claims that some wellness centers and websites are selling unauthorized versions of these drugs made with unapproved chemicals and marketed as generic versions, even though Lilly does not produce generic versions of its drugs. These counterfeit products are dangerous because they may contain incorrect dosages, wrong medications, no medication, or a mix of several medications, posing serious health risks.
According to Lilly, fake tirzepatide — the active ingredient in Mounjaro and Zepbound — has been found to contain bacteria, high levels of impurities, and different chemicals than genuine drugs. These fake products often have safety, efficacy, and sterility issues.
The FDA does NOT approve
Counterfeiting is not limited to tirzepatide. In December, the FDA warned against using counterfeit semaglutide, the active ingredient in Ozempic and Wegovy, due to potential adverse events such as infections and abdominal pain. Since 2020, the FDA has received over 100 adverse event reports related to counterfeit tirzepatide and semaglutide, including several life-threatening cases, 19 hospitalizations, and at least two deaths.
How to spot a fake
To identify fake GLP-1 drugs, Lilly advised looking for a pink hue in the product (genuine versions are colorless), generic labeling (neither Lilly nor Novo Nordisk sells generic versions), incorrect dosages, grammatical errors on the packaging, lack of tamper-resistant features, and mismatched batch numbers.
The reason for the fakes is to meet the demand
The National Association of Boards of Pharmacy has noted that high demand and short supply of these drugs have led to the sale of substandard and falsified versions, putting patients at risk. Both Wegovy and Ozempic, as well as Zepbound and Mounjaro, have experienced shortages due to high demand. Lilly warned that fake versions of its products are also being sold online and on social media, where it does not sell genuine Mounjaro or Zepbound.
Current steps being taken by the drug makers
In its letter, Lilly also announced legal action against medspas, wellness centers, and clinics selling unapproved and counterfeit versions of its drugs. The company claims these clinics falsely market the fake products as Mounjaro and Zepbound, misuse Lilly’s clinical trial results, and deceptively use the FDA’s approval of genuine drugs to sell the counterfeits.
Lilly has previously filed similar lawsuits and settled with one company, Totality Medispa, which agreed to comply with federal law and report all adverse events to the FDA. Novo Nordisk has also filed lawsuits against nine wellness clinics for selling compounded versions of Ozempic and Wegovy, some of which contained up to 24% impure chemicals. Novo Nordisk is seeking to stop these companies from marketing and selling products claiming to contain semaglutide and is asking for compensation of up to $75,000.
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Source: “WHO warns about fake versions of weight loss drugs Wegovy and Zepbound,” NBC News, 6/20/24
Source: “Weight-Loss Drugs Dangers Explained: Zepbound, Mounjaro Maker Warn Of Coming Counterfeit Lawsuit,” Forbes, 6/20/24
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