Eli Lilly and Company
1 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
The video omits an important concept from the boxed warning for both drugs; specifically the contraindication in patients with a personal or family history of MEN 2 due to the risk of thyroid c-cell tumors.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The video omitted the MEN 2 contraindication from the boxed warning for Zepbound and Mounjaro.
Supporting FDA text
Source excerpt · automated text-match checkThe video omits an important concept from the boxed warning for both drugs; specifically the contraindication in patients with a personal or family history of MEN 2 due to the risk of thyroid c-cell tumors.
The video omitted multiple serious warnings and precautions for both drugs, including severe GI disease, acute kidney injury, hypersensitivity, hypoglycemia, diabetic retinopathy, and suicidal ideation.
Supporting FDA text
Source excerpt · automated text-match checkAdditionally, several warnings and precautions associated with Zepbound and Mounjaro are also completely omitted from the video. Specifically, serious risks pertaining to severe gastrointestinal disease, acute kidney injury, hypersensitivity reactions, hypoglycemia, diabetic retinopathy complications in patients with type 2 diabetes mellitus, and suicidal behavior and ideation, which are described in the “What are the possible side effects of ZEPBOUND?” section of the Medication Guide, are omitted from the video. Furthermore, similar warnings and precautions for Mounjaro, as described in the “What are the possible side effects of MOUNJARO?” section of the Medication Guide, are also omitted from the video.
Statements in the video minimized the boxed warning and serious risks, including thyroid cancer, pancreatitis, and gallbladder complications.
Supporting FDA text
Source excerpt · automated text-match checkThese statements by Dr. Velazquez misleadingly minimize the serious risks of Zepbound and Mounjaro, including the boxed warning.
The video used phrases like 'a lot of hype' and 'overhyped' to misleadingly downplay the severity of risks.
Supporting FDA text
Source excerpt · automated text-match checkThe use of phrases such as “a lot of hype” and “overhyped” when referring to risk information misleadingly undermines the risk’s importance and severity.
The video falsely described side effects as 'mild to moderate' when that has not been demonstrated.
Supporting FDA text
Source excerpt · automated text-match checkThese statements also minimize the risks by describing them as “mild to moderate,” when this has not been demonstrated.
The video presented risk information with less prominence and readability than benefit information, undermining risk communication.
Supporting FDA text
Source excerpt · automated text-match checkFinally, the video is also misleading because it fails to present information related to side effects and contraindications for Zepbound and Mounjaro with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of Zepbound and Mounjaro.
The video was not submitted to FDA under Form FDA-2253 at the time of initial publication as required.
Supporting FDA text
Source excerpt · automated text-match checkA copy of the video was not submitted to FDA under cover of Form FDA-2253 at the time of initial publication as required by 21 CFR 314.81(b)(3)(i).
Findings extracted from the letter
Selected FDA passages, not the complete letter.
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- A written response addressing the concerns described in the letter, listing all other promotional communications (with the 2253 submission date) for Zepbound and Mounjaro that contain representations such as those described above, and explaining the plan for discontinuation of such communications or for ceasing distribution of Zepbound and Mounjaro.
- A comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concerns discussed in the letter, to be disseminated to the audience(s) that received the promotional communication(s) identified in the opening paragraph.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.