Lilly warns public not to use tirzepatide for cosmetic weight loss
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Eli Lilly and Co. released an open letter stating its tirzepatide products should not be used for cosmetic weight loss and warning the public about the circulation of compounded and counterfeit tirzepatide.
“Patient safety is Lilly’s top priority, and we actively engage in monitoring, evaluating and reporting safety information for all our medicines,” the letter stated. “We are aware of certain practices relating to our tirzepatide medicines that we wish to address publicly to ensure that our medicines are prescribed and used safely.”
As Healio previously reported, the FDA approved tirzepatide (Mounjaro/Zepbound, Eli Lilly) to improve glucose control in addition to diet and exercise for adults with type 2 diabetes, in May 2022, and for chronic weight management in addition to a reduced-calorie diet and increased physical activity among adults with obesity or overweight with one weight-related comorbidity, in November 2023.
In its open letter release on January 4, the company stated that tirzepatide is FDA approved only for type 2 diabetes and obesity and should not be used for cosmetic weight loss. The letter stated people should use tirzepatide only when prescribed by a licensed health care professional. The medication is not recommended for use among people with severe gastrointestinal disease, including severe gastroparesis, as it has not yet been studied in this population.
Lilly also stated that it is the sole manufacturer of tirzepatide, and the drug is available only in pre-filled single-dose pens or vials. Drugs labeled tirzepatide that are not manufactured by Lilly may lead to serious health risks. This includes compounded tirzepatide, about which, the letter stated, the company is extremely concerned. Some compounded tirzepatide tested by Lilly contains high amounts of impurities and in one instance, consisted only of sugar alcohol.
“Lilly has commenced legal action against certain medical spas, wellness centers, compounding pharmacies making and/or selling products claiming to contain the active pharmaceutical ingredient for tirzepatide,” the letter stated. “Lilly also has commenced legal action against importers and distributors of these products, as well as against other counterfeit sources that are fraudulently claiming to sell Mounjaro, Zepbound or tirzepatide medicines.”
Lilly’s letter comes less than a month after the FDA voiced similar concerns about counterfeit semaglutide (Ozempic/Wegovy, Novo Nordisk) that may be circulating in the U.S. drug supply chain.
Health care providers should review the instructions for use that accompany tirzepatide products. Full prescribing information for Mounjaro and Zepbound are available at the Lilly website.
Patients who are worried that they may have received or used compounded or counterfeit tirzepatide should contact their health care provider. Counterfeit products can be reported to the Lilly Answers Centers at (1-800) 545-5979.
Perspective
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Fatima Cody Stanford, MD, MPH, MPA, MBA, FAAP, FACP, FAHA, FAMWA, FTOS
Tirzepatide is a highly effective drug for the treatment of obesity and type 2 diabetes. However, there is a risk of misuse if these medications are compounded, which means that they have yet to undergo any rigorous testing and safety protocols. I never recommend any compounded agents to my patients for these reasons.
Additionally, these medications should be prescribed by licensed physicians and other health professionals with training in the field of cardiometabolic health and obesity. For those who do not have such training, they may be improperly titrating doses of these medications, which may lead to adverse outcomes.
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Open letter regarding the use of Mounjaro (tirzepatide) and Zepbound (tirzepatide). Available at https://investor.lilly.com/news-releases/news-release-details/open-letter-regarding-use-mounjaror-tirzepatide-and-zepboundtm. Published Jan. 4, 2024. Accessed Jan. 4, 2024.
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