Drugmaker Eli Lilly on Thursday warned against using its diabetes and obesity drugs for “cosmetic” weight loss, as the medications have exploded in popularity, resulting in shortages.
In an open letter posted online, the company said its products 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 said it does not “promote or encourage” the use of any of its medicines outside of the approved indication. Neither Zepbound nor Mounjaro are approved for anyone who doesn’t have a diagnosis of obesity or Type 2 diabetes, among other weight-related conditions. The drugs are meant for long-term use to treat chronic conditions, not quick weight loss.
Both of Lilly's drugs are part of an emerging, and expensive, class called GLP-1 agonists, which also includes Novo Nordisk’s Ozempic and Wegovy. They all have a list price of more than $1,000 per month and are often not covered by insurance, which puts them out of reach for many Americans.
The drugs became extremely popular after being touted by celebrities and online influencers, and doctors have been prescribing them off-label for weight loss. As a result, Ozempic and Wegovy are experiencing shortages, and patients with diabetes are having difficulty accessing the treatment they need.
Zepbound was approved in November for patients with obesity, while Mounjaro was approved only for diabetes. Both share the same active ingredient tirzepatide. Lilly last week said Zepbound was available in retail and mail-order pharmacies.
Lilly also cautioned against knock-off products that may contain impurities and expose patients to potentially serious health risks, and it said it was taking legal action against spas and wellness centers that use products claiming to contain the active ingredient in tirzepatide.
“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,” the company said.
The warning came on the same day Lilly launched a new direct-to-consumer prescribing service to help patients with obesity, diabetes and migraines to get a prescription for through a telemedicine provider.
The company said its website LillyDirect will save patients money and help improve access to drugs like Zepbound and Mounjaro. Patients who are prescribed Lilly's drugs will be eligible for the free at-home prescription delivery service, but doctors will be able to prescribe any drug.
There won't be any price discounts, but Lilly said patients using the service will have easier access to financial help like its savings card program.
Lilly is contracting with an independent third-party telehealth provider, and won't be providing the services itself. The company said the providers could complement a patient's current primary care team or be an "alternative to in-person care for certain conditions."
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