Don Tracy, Associate Editor

Company cites potential safety risks for patients who ignore the intended indication of Mounjaro and Zepbound.

In a letter to the public, Eli Lilly and Company warned against the use of its medicines for cosmetic weight loss. Citing the fact that neither Mounjaro or Zepbound are indicated for cosmetic purposes, the pharma company stressed that both are intended to treat serious diseases, with Mounjaro focusing on type 2 diabetes and Zepbound for obesity in specific BMI ranges of a BMI of 30 kg/m2 or greater or those who are overweight with a BMI ≥ 27 kg/m2 or greater. Additionally, caution is advised for patients with severe gastrointestinal conditions and the medications should only be prescribed by licensed healthcare professionals.

“Patients should consult with their healthcare providers to determine whether Mounjaro or Zepbound is right for them,” the company stated in a press release. “Mounjaro and Zepbound have not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and are therefore not recommended in these patients.”

Eli Lilly also has expressed concerns about safety risks associated with compounded tirzepatide products from unauthorized sources. Legal action has been taken against entities producing or distributing such products, including medical spas, wellness centers, and importers.

“Compounding pharmacies mix and combine ingredients to make customized medications based on a specific prescription (e.g., due to allergies to an ingredient),” the press release stated. “Products claiming to contain tirzepatide, Mounjaro, or Zepbound that are made and/or distributed by compounding pharmacies have not been reviewed by the FDA or global regulatory agencies for safety, quality, or efficacy; are not FDA-approved or approved by global regulatory agencies like Mounjaro and Zepbound; and may expose patients to potentially serious health risks.”

Last October, Lilly filed a complaint with the US International Trade Commission against 11 online pharmacies, aiming to prevent them from importing, selling, or distributing products with tirzepatide. Currently, it is the only drugmaker that is authorized by the FDA to sell products containing it.

Also in October, a suspected knockoff of Novo Nordisk’s Ozempic resulted in several people being hospitalized in Austria. Reports indicated that the patients suffered from hypoglycemia and seizures, adverse effects that determine the products contained insulin as opposed to semaglutide, Ozempic’s key ingredient. The Danish drugmaker had previously warned of online offers of counterfeit Ozempic and Wegovy.

“Patients prescribed semaglutide injectable products, FDA-approved and marketed under the brand names Ozempic and Wegovy, should be vigilant in checking their medicine to ensure they are taking an authentic, Novo Nordisk produced version of the authorized drug and injection device,” the company said in a June 2023 statement. “The safety or efficacy of counterfeit products cannot be assured and they should not be used. Potential risks of taking a counterfeit medicine include serious adverse events.”

Both Lilly and Novo Nordisk have provided tips on identifying counterfeit products, aiming to prevent any adverse reactions.

“If a patient is concerned that they may have received or used compounded or counterfeit tirzepatide, the patient should contact their healthcare provider to discuss their concerns and options,” Lilly stated in the release. “Patients and healthcare providers are encouraged to report counterfeit (“fake”) Mounjaro and Zepbound products to the Lilly Answers Center (TLAC) at 1-800-LillyRx (1-800-545-5979).”