Eli Lilly, the pharmaceutical company, has issued an open letter addressing the misuse of its FDA-approved tirzepatide medicines, Mounjaro and Zepbound, for cosmetic weight loss. The company emphasizes that these drugs are intended for the treatment of serious diseases, not for cosmetic purposes.
Mounjaro is indicated to improve glycemic control in adults with type 2 diabetes mellitus, while Zepbound is intended for adults with obesity or those who are overweight and have at least one weight-related additional condition. Both drugs should only be used when prescribed by a licensed healthcare professional.
Eli Lilly has also expressed concern about the safety risks of using compounded tirzepatide, which are products claiming to contain tirzepatide, Mounjaro, or Zepbound that are made and/or distributed by compounding pharmacies. These products have not been reviewed by the FDA or global regulatory agencies for safety, quality, or efficacy, and may expose patients to potentially serious health risks.
The company has initiated legal action against certain medical spas, wellness centers, and compounding pharmacies that are making and/or selling products claiming to contain the active pharmaceutical ingredient (API) for tirzepatide. The goal of these lawsuits is to protect patients from the unlawful marketing, sale, distribution, and importation of non-FDA approved compounded tirzepatide products.
Eli Lilly urges patients and healthcare providers to report counterfeit ("fake") Mounjaro and Zepbound products to the Lilly Answers Center. The company remains committed to patient safety and encourages healthcare providers to review the Instructions for Use that accompany Mounjaro and Zepbound, as well as the important information about the drugs' risks contained in the Full Prescribing Information and Medication Guide for both medications.
As someone who has been prescribed Mounjaro for the treatment of type 2 diabetes, I can personally attest to the importance of using this medication as directed by a healthcare professional. I have not experienced any side effects or issues since I started using Mounjaro, and I strongly advise against the misuse of such medications for non-prescribed purposes, such as cosmetic weight loss. It's crucial to remember that these are serious medications intended for the treatment of serious health conditions, and their misuse can lead to potentially severe health risks.
Frequently Asked Questions
What specific legal actions has Eli Lilly taken against unauthorized sellers, and what has been the outcome of these actions?
Eli Lilly has initiated legal actions against various entities, including medical spas, wellness centers, and compounding pharmacies, for making and/or selling products that falsely claim to contain the active pharmaceutical ingredient (API) for tirzepatide. These lawsuits target the unlawful marketing, sale, distribution, and importation of non-FDA approved compounded tirzepatide products. The company's goal with these legal actions is to protect patients from potentially serious health risks associated with these unauthorized products. Eli Lilly is committed to considering all available legal remedies against these actors to enforce its policies and ensure patient safety.
Are there any ongoing studies or research to potentially approve tirzepatide for cosmetic use in the future?
There are no ongoing studies or research specifically aimed at approving tirzepatide (Mounjaro and Zepbound) for cosmetic use in the future. Eli Lilly's stance, as outlined in the document, is firmly against the use of its tirzepatide medicines for cosmetic weight loss. The company emphasizes that Mounjaro and Zepbound are intended for the treatment of serious diseases, such as type 2 diabetes mellitus and obesity or overweight with at least one weight-related additional condition, and not for cosmetic purposes.
How does Eli Lilly plan to enforce its policies against the misuse of tirzepatide more effectively, beyond legal action and urging reporting?
Beyond taking legal action, Eli Lilly urges patients and healthcare providers to report counterfeit ("fake") Mounjaro and Zepbound products to the Lilly Answers Center. This proactive approach of encouraging reporting is part of the company's broader strategy to combat the misuse of tirzepatide. Additionally, Eli Lilly emphasizes the importance of healthcare providers reviewing the Instructions for Use that accompany Mounjaro and Zepbound, as well as the important information about the drugs' risks contained in the Full Prescribing Information and Medication Guide for both medications. These measures are aimed at ensuring that the medications are prescribed and used safely, in accordance with FDA-approved indications.
Press Release (Updated June 20, 2024)
