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Officials at Eli Lilly have posted an open letter regarding the use of its FDA-approved tirzepatide medications, Mounjaro and Zepbound, for cosmetic weight loss.
The company stated that it was aware of the practice of these drugs being prescribed or used outside of the parameters of the Food and Drug Administration as well as the use of tirzepatide by compounding pharmacies that mix customized medicines.
“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,” the statement reads.
“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,” the officials added.
Mounjaro is available in injectable single-dose pens or vials.
It is recommended for adults with type 2 diabetes to improve blood sugar, but it is meant to be combined with dietary and exercise changes.
There is an FDA warning on Mounjaro about a potential increased risk for thyroid cancer.
Other side effects include:
Zepbound is also injectable and is meant for adults who are overweight or have obesity.
The company’s recommendation is that it be used with a reduced-calorie diet and an increase in physical activity.
Zepbound also has an FDA warning about potential thyroid cancer risk.
Other side effects include:
In referring to drugs containing tirzepatide, Dr. Dan Azagury, FACS, the chief bariatric surgeon and medical director of Stanford University School of Medicine’s Lifestyle and Weight Management Clinic in California, said using the medications for cosmetic purposes is not recommendable.
Aside from the side effects, he said the drugs can create longer-term problems for people who are trying to lose weight quickly rather than applying dietary and exercise regimens over time for overall health.
“We tell our patients that if they start the drug they should do so being comfortable with the idea of staying on it forever,” Azagury told Healthline. “Because often when you stop there is a rebound effect. In particular, if you stop abruptly. Patients who take this just to lose 5 to 10 pounds and stop will then likely regain 10 to 15 pounds, leading to worse long-term outcomes and a yo-yo effect that is unfavorable. I think educating patients in that way would be beneficial.”
Ozempic, along with drugs such as Wegovy, are commonly called GLP-1 drugs, or glucagon-like peptide1 receptor agonists. Tirzepatide drugs are part of the GLP-1 class.
Ozempic is meant to be prescribed to adults with type 2 diabetes to help lower risks of heart disease and manage blood sugar levels, but it is also prescribed off-label — where a drug that’s approved for certain conditions is prescribed for another purpose — for weight loss or weight management.
Wegovy is recommended with exercise and a low calorie diet for long-term weight loss in:
All GLP-1 drugs have been found to be linked to serious gastrointestinal side effects, some of which can require hospitalization.
Research published in October 2023 reported strong associations with intestinal blockage and pancreatitis in users of GLP-1 drugs.
Azagury said that the use of these type of drugs for purposes other than those approved by the FDA can change the risk factors for people.
“Every drug has side effects and potential risks. When the FDA approves a drug, they weight the benefits vs the risks,” Azagury said. “They issue an indication for use based on that equation. If you’re doing it for cosmetic purposes with no health benefit, then that equation is different and the side effects or risks might outweigh the benefits.”
Dr. Mir Ali, a bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in California, said the statement by Eli Lilly will likely make no difference on how people look for cosmetic weight loss treatments.
“Patients seeking these medications for weight loss will try to obtain them regardless of any warnings,” Ali told Healthline. “These medicines are in short supply because the demand is so high. Many patients who do not meet the manufacturers’ guidelines are seeking these medications for weight loss. These medicines are more effective than diet and exercise alone, so people who do not have significant weight view them as a more convenient solution.”
That type of demand, Azagury said, is also creating problems or people for whom tirzepatide drugs would be beneficial for long-term health.
“It’s unfortunate because this is an expensive drug that is extremely beneficial to patients with obesity and they have difficulty accessing it,” he said. “Its use for cosmetic by people who can afford it is increasing disparities and reducing access for patients who would truly benefit.”
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