FDA says Eli Lilly videos for Zepbound and Mounjaro downplayed risks
The letters say two Lilly videos left out the boxed warning's MEN 2 contraindication and other labeled risks that patients rely on when weighing these drugs.
FDA sent Eli Lilly warning letters dated Sept. 9, 2025 over videos promoting its tirzepatide drugs Zepbound and Mounjaro, saying the videos misled viewers about serious risks and misbrand the products [1][2].
One letter covers "An Oprah Special: Shame, Blame, and the Weight Loss Revolution," a 42-minute prime-time special that first aired on ABC on March 18, 2024 and appeared on Hulu the next day [1]. The special featured two paid Lilly consultants, Dr. W. Scott Butsch and Dr. Amanda Velazquez, and Lilly's Rhonda Pacheco, group vice president of diabetes and obesity [1].
Winfrey asked the doctors about serious health effects down the road. Dr. Velazquez answered that there has been "a lot of hype around like pancreatitis, gallbladder complications, concerns for thyroid cancer," that this "has really not been shown in human studies," and that "really the risk is less than 1%" [3]. FDA wrote that the statements "misleadingly minimize the serious risks of Zepbound and Mounjaro, including the boxed warning" [1][3]. The agency's letter also said it was concerned the company kept promoting the drugs this way despite earlier advisory comments [1].
FDA said the special left out that both drugs are contraindicated for people with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), part of the boxed warning about thyroid C-cell tumors. Dr. Velazquez discussed medullary thyroid cancer but not MEN 2, according to the letter [1][3]. FDA also said the video omitted labeled warnings and precautions for severe gastrointestinal disease, acute kidney injury, hypersensitivity reactions, hypoglycemia, suicidal behavior and ideation, and diabetic retinopathy complications in patients with type 2 diabetes [1][3].
A second warning letter covers a Zepbound interview posted on okcfox.com that originally appeared on Fox25's "Living Oklahoma" website on July 11, 2025. It featured Dr. Clare Lee, Lilly's associate vice president of medical affairs, and Ms. Pacheco [2]. FDA said the video opened with a disclaimer that the segment was sponsored by Eli Lilly, contained no risk information at all, and did not disclose the drug's limitations of use [2].
Both letters note that FDA had already sent Lilly advisory comments about Mounjaro promotions in June 2022 and about Zepbound promotions in May and November 2024 [1][2].
According to the labels FDA cited, Zepbound is approved for chronic weight management in adults with a body mass index of 30 or higher, or 27 or higher with at least one weight-related condition such as high blood pressure or type 2 diabetes. Mounjaro is approved to improve blood sugar control in adults with type 2 diabetes [1]. Common side effects listed for both include nausea, diarrhea, vomiting, constipation and abdominal pain [1]. FDA described both as drugs with "multiple serious, potentially life-threatening risks" and said patients should receive truthful, non-misleading information [1].
FDA also sent Novo Nordisk a letter about the same special, and Lilly received three letters in all covering different promotions; the letters were released as part of a broader enforcement push that included other drugmakers [3].
Why it matters for patients
The letters are about advertising, not new findings about how often these risks occur. FDA did not say the risks are more common than the labels describe, only that the promotions failed to present them truthfully and completely [1][2]. Nothing in the letters changes which patients Zepbound or Mounjaro are approved for, and they do not replace the prescribing information or medication guide [1][2].
What FDA says was left out, including the MEN 2 and MTC contraindication, pancreatitis and gallbladder warnings, severe gastrointestinal disease, kidney injury, hypoglycemia and suicidal thinking, is already described in those documents [1]. FDA said the audience for the special included millions of adults and vulnerable groups such as children [1]. It has not been disclosed whether the videos are still available or whether any part of them has been changed.
What happens next
FDA asked Lilly for a written response within 15 working days of receiving each letter, listing other promotions with the same claims and explaining a plan to stop them [2]. FDA also asked the company to propose corrective communications, free of promotional claims, delivered to the same audiences and using the same media where possible [2]. The letters say failure to address the violations could lead to legal action, including seizure and injunction [2].
It has not been disclosed whether Lilly has responded. No further deadlines have been announced [1][2].
Sources
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eli-lilly-and-company-716485-09092025
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eli-lilly-and-company-716462-09092025
- https://www.biospace.com/policy/fdas-ad-crackdown-targets-novo-lillys-oprah-special-on-glp-1s
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