Indiapolis – Lilly is committed to meeting the needs of people affected by diabetes and obesity with treatment options that change the way healthcare providers can treat these diseases and offer breakthroughs for patients. The development and approvals of Mounjaro and Zepbound demonstrate our continued commitment to this mission.
Patient safety is Lilly’s top priority, and we actively engage in monitoring, evaluating, and reporting safety information for all our medicines. 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.
Lilly Stands Against the Use of its Medicines for Cosmetic Weight Loss: Mounjaro and Zepbound are indicated for the treatment of serious diseases; they are not approved for – and should not be used for – cosmetic weight loss.
- Lilly does not promote or encourage use of Mounjaro, Zepbound, or any Lilly medicines outside of a medicine’s FDA-approved indication.
- Mounjaro is indicated in addition to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- Zepbound is indicated for adults with obesity (with a BMI of 30 kg/m2 or greater) or those who are overweight (with a BMI ≥ 27 kg/m2 or greater) and also have at least one weight-related additional condition, such as hypertension (high blood pressure), dyslipidemia (high cholesterol or fats in blood), type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease, to lose weight. It should be used with a reduced-calorie diet and increased physical activity.
- Mounjaro and Zepbound should only be used when prescribed by a licensed healthcare professional. Patients should consult with their healthcare providers to determine whether Mounjaro or Zepbound is right for them. Mounjaro and Zepbound have not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and are therefore not recommended in these patients.
- Healthcare providers should review the Instructions for Use that accompany Mounjaro and Zepbound and the important information about Mounjaro’s and Zepbound’s risks contained in the Full Prescribing Information and Medication Guide for both medications. Please click to access the full Prescribing Information and Medication Guide for Mounjaro. Please click to access the full Prescribing Information and Medication Guide for Zepbound.
- If a healthcare provider has questions about the use of Lilly’s tirzepatide medicines, they are encouraged to chat directly with a Lilly Medical Professional here or contact Lilly at 1-800-LillyRx (1-800-545-5979).
There are Safety Risks of Using Compounded Tirzepatide: Compounding pharmacies mix and combine ingredients to make customized medications based on a specific prescription (e.g., due to allergies to an ingredient). 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.
- Mounjaro and Zepbound are only available from and manufactured by Lilly, and they are only available for sale in pre-filled single-dose pens or single-dose vials. Lilly is the only approved supplier of FDA-approved tirzepatide medicines in the United States.
- Tirzepatide products not manufactured by Lilly may expose patients to potentially serious health risks. Products falsely claiming to be Mounjaro, Zepbound, or tirzepatide have not undergone FDA review or review by global regulatory agencies for safety, effectiveness, and quality, and are not FDA-approved like Mounjaro and Zepbound.
- Lilly is extremely concerned that some of the compounded tirzepatide that Lilly has tested has contained high amounts of impurities, and, in at least one instance, was actually nothing more than 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 (API) for tirzepatide. 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.
- Our goal in filing these lawsuits is to protect patients from the unlawful marketing, sale, distribution, and importation of non-FDA approved compounded tirzepatide products. Lilly will continue to consider all available legal remedies against these actors.
- 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. 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).