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WARNING LETTER

Eli Lilly and Company MARCS-CMS 716485 —

Product:
Drugs
Recipient:
Recipient Name
David A. Ricks
Recipient Title
Chief Executive Officer
Eli Lilly and Company

Lilly Corporate Center
Indianapolis, IN 46285
United States

Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

RE: NDA 217806 and 215866
ZEPBOUND® (tirzepatide) injection, for subcutaneous use
MOUNJARO® (tirzepatide) injection, for subcutaneous use
MA 974 and 832

WARNING LETTER

Dear David A. Ricks:

The U.S. Food and Drug Administration (FDA) has reviewed the promotional communication, a direct-to-consumer video (video), titled “An Oprah Special: Shame, Blame, and the Weight Loss Revolution,” regarding ZEPBOUND® (tirzepatide) injection, for subcutaneous use (Zepbound) and MOUNJARO® (tirzepatide) injection, for subcutaneous use (Mounjaro). The video features Dr. W. Scott Butsch1 and Dr. Amanda Velazquez2, paid consultants (representatives) who “receive research funding from companies making GLP-13 drugs.”4 The video also features Rhonda Pacheco,5 Group Vice President of Diabetes and Obesity for Eli Lilly and Company (Eli Lilly). The video originally appeared on ABC as a Primetime Oprah Special on March 18, 2024 and can also be accessed through ABC’s website.6 The video subsequently appeared on Hulu on March 19, 2024. FDA has determined that the video is false or misleading. Thus, the video misbrands Zepbound and Mounjaro within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and makes its distribution violative. 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1 (e)(5); (e)(7)(viii). In addition, these materials were not submitted at the time of initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i). These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the safety of Zepbound and Mounjaro, which are drugs with multiple serious, potentially lifethreatening risks, including a boxed warning for the risk of thyroid C-cell tumors. Obesity and excessive weight and type 2 diabetes mellitus are significant public health concerns that affect vulnerable populations (e.g., children) and millions of adults in the United States and are associated with numerous co-morbidities. Consumers and patients who seek medical treatment for managing obesity and excessive weight or their type 2 diabetes mellitus should receive truthful and non-misleading information regarding the serious risks associated with the use of a weight management prescription drug product, such as Zepbound, and with the use of a type 2 diabetes prescription drug product, such as Mounjaro.

Background

Below are the indication and summary of the most serious and most common risks associated with the use of Zepbound and Mounjaro.7 According to the INDICATIONS AND USAGE section of the respective FDA-approved prescribing information (PI)8,9 (in pertinent part):

ZEPBOUND® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

  • 30 kg/m2 or greater (obesity) or
  • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease).

Limitations of Use:

  • ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.
  • The safety and efficacy of ZEPBOUND in combination with other products intended for weight management, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
  • ZEPBOUND has not been studied in patients with a history of pancreatitis.

The PI for Zepbound contains a boxed warning regarding the risk of thyroid C-cell tumors. Zepbound is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Zepbound is also contraindicated in patients with a known serious hypersensitivity to tirzepatide or any of the excipients in Zepbound. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide. In addition, the PI for Zepbound includes warnings and precautions regarding severe gastrointestinal disease, acute kidney injury, acute gallbladder disease, acute pancreatitis, hypersensitivity reactions, hypoglycemia, diabetic retinopathy complications in patients with type 2 diabetes mellitus, and suicidal behavior and ideation. The most common adverse reactions observed with Zepbound were nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease.

MOUNJARO ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

  • MOUNJARO has not been studied in patients with a history of pancreatitis.
  • MOUNJARO is not indicated for use in patients with type 1 diabetes mellitus.

The PI for Mounjaro contains a boxed warning regarding the risk of thyroid C-cell tumors. Mounjaro is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Mounjaro is also contraindicated in patients with a known serious hypersensitivity to tirzepatide or any of the excipients in Mounjaro. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with Mounjaro. In addition, the PI for Mounjaro includes warnings and precautions regarding pancreatitis, hypoglycemia with concomitant use of insulin secretagogues or insulin, hypersensitivity reactions, acute kidney injury, severe gastrointestinal disease, diabetic retinopathy complications in patients with a history of diabetic retinopathy, and acute gallbladder disease. The most common adverse reactions observed with Mounjaro were nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.

Prior Communications

FDA notes that advisory comments dated June 13, 2022 and June 21, 2022, to Eli Lilly addressed draft promotional presentations for Mounjaro with certain similarities to the video in this letter. In these advisory comments, FDA recommended revising draft promotional communications to avoid minimizing the risk of gastrointestinal adverse reactions associated with Mounjaro, or otherwise misrepresenting important risk information.10

We are concerned that Eli Lilly is promoting Zepbound and Mounjaro in a manner that fails to present the serious risks of these drug products in a truthful and non-misleading manner despite FDA’s prior comments.

False or Misleading Risk Presentation

Prescription drug advertisements and labeling (promotional communications) misbrand a drug if they are false or misleading with respect to risk. The determination of whether a promotional communication is misleading includes, among other things, not only representations made or suggested in the promotional communication, but also the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication.

The video is a 42-minute special program, hosted by Oprah Winfrey, concerning the “new drugs sparking... a weight loss revolution...that have captured the world’s attention”11 due to “so-called miracle medications like Ozempic, Wegovy, Mounjaro, and Zepbound.” The video features testimonials from those who struggle with obesity and excessive weight, including those who have used these drug products to help lose weight. The video also prominently features two paid consultants of Eli Lilly, Drs. Butsch and Velazquez,12 who are asked about their experiences with treating patients who are obese or have excess weight, and the use of these medications. The Eli Lilly Group Vice President of Diabetes and Obesity, Rhonda Pacheco, is also featured at the end of the video to discuss access to their drug products, Zepbound and Mounjaro. At approximately 12 minutes and 30 seconds into the video, Ms. Winfrey introduces Dr. Butsch using a pre-recorded cut-away where he provides information to the audience about the complexity of obesity as a medical condition. Ms. Winfrey then introduces Dr. Velazquez at approximately 16 minutes and 40 seconds using another prerecorded cut-away with the preface that they will now ask “how these medications actually work.” Dr. Velazquez describes in the cut-away how the “newer agents like GLP-1s” are a “new era for the treatment of obesity.” Dr. Velazquez continues by describing how our naturally occurring GLP-1 hormone works in the body and how drugs, like Zepbound and Mounjaro, are “essentially copying what our normal GLP-1 hormone does in our body, but doing it a little bit better.” Throughout the remainder of the cut-away, Dr. Velazquez provides more details about the clinical and metabolic processes associated with GLP-1s and how the medications, compared to previous obesity and excessive weight treatments, have achieved “double the amount of weight loss.” Ms. Winfrey then continues the conversation with both Drs. Butsch and Velazquez on-stage about the benefits of the medications, and then concludes this segment of the video (20:05) by asking “Both of you are consultants to the drug companies, what does that mean?” Dr. Velazquez answers that “…they are looking for our expert opinion to be able to deliver high quality care to patients” and Dr. Butsch further states “I’ve been involved with some of these companies in developing education programs and modules for medical students and medical trainees to learn more about the disease of obesity. I’m also running clinical trials with future medications.”

The video includes numerous representations about the benefits of Zepbound and Mounjaro made by representatives of Eli Lilly, but omits important risk information and otherwise minimizes the risks of these drug products. We note that the video includes a segment on “the side effects” of GLP-1s, generally (beginning at 33:35 and ending at 37:47). However, this segment begins with a description from a non-Eli Lilly affiliated health care provider about how patients should be weighing the risks and benefits of taking any GLP-1 drug and, as explained below, concludes after several misleading omissions and statements are made by representatives of Eli Lilly about the risks of Zepbound and Mounjaro.13

First, 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. While Dr. Velazquez does provide a limited discussion of the thyroid risk to “anybody [who] has a history specifically of medullary thyroid cancer,” the risk to patients with a history of MEN 2 is omitted. The boxed warning in the Zepbound and Mounjaro PIs states the following (in pertinent part; bolded emphasis original, underlined emphasis added):

ZEPBOUND [and MOUNJARO] is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) . . . . Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND [and MOUNJARO] and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).

Additionally, 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.

These omissions are further exacerbated by statements made by Dr. Velazquez in the video that misleadingly minimize and downplay the drugs’ boxed warning, contraindications, warnings and precautions and other common adverse events. For example, when Ms. Winfrey asks about “serious health effects down the road” from treatment with GLP-1 medications, like Zepbound and Mounjaro (36:56), Dr. Velazquez responds (emphasis added):

  • “There’s been a lot of hype around like pancreatitis, gallbladder complications, concerns for thyroid cancer. This has really not been shown in human studies that this is a downstream complication, and that really the risk is less than 1%.” (37:00)
  • “If anybody has a history specifically of MTC... is very, very rare. So if they do have that, we are not prescribing that medication. So, we have to be able to keep up with knowing the data, and recognizing that it’s rare, but it’s there and we have to always screen.” (37:19)

These statements by Dr. Velazquez misleadingly minimize the serious risks of Zepbound and Mounjaro, including the boxed warning. A boxed warning is ordinarily used to highlight for prescribers when there is an adverse reaction so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drug. We note that the Agency has informed Lilly to conduct a MTC registry-based case series study of at least 15 years duration to systemically monitor the annual incidence of MTC in the United States and to identify any increase related to the introduction of tirzepatide into the marketplace. While we acknowledge that current data is insufficient to establish or exclude a causal relationship between MTC and Zepbound and Mounjaro, it is misleading to describe this risk as such because there is a boxed warning across the entire GLP-1 pharmacological class.

These statements are also concerning because they misleadingly minimize the serious risks associated with Zepbound and Mounjaro by suggesting that a patient does not need to be worried about the potential for developing “pancreatitis,” “gallbladder complications,” and “thyroid cancer” from treatment with Zepbound and Mounjaro. Specifically, the statements that “there’s been a lot of hype” about the risks and they are “rare, but…there” are especially egregious, given the nature of the risks to patients from GLP-1 treatment, including pancreatitis, which has led to serious complications. According to the WARNINGS AND PRECAUTIONS, Acute Pancreatitis, section of the Zepbound and Mounjaro PIs, “acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists or tirzepatide.” Moreover, “gallbladder complications,” such as acute gallbladder disease, were observed in patients treated with Zepbound and Mounjaro, and is a warning and precaution across the entire GLP-1 pharmacologic class, since GLP-1 drug treatment has led to hospitalization and cholecystectomy (gallbladder removal) in some patients.

Additional statements made in the video, with respect to the common adverse reactions for Zepbound and Mounjaro, are similarly misleading since they suggest that Zepbound and Mounjaro are safer because the adverse events are less common and less severe than have been demonstrated. For example, when asked to respond to the concerns of a guest patient that experienced side effects from using GLP-1s and subsequently had to discontinue treatment, the following conversation occurs (emphasis added):

  • Ms. Winfrey: (after speaking to the guest patient “Rolanda” about her need to discontinue treatment with a GLP-1 medication due to side effects, such as becoming “very nauseous” and vomiting blood) “So Dr. Velazquez, what do you want to say about that?” (36:37)
  • Dr. Velazquez: “Yeah, I think that it’s about education of the side effects. It’s about effective management of the side effects.” (36:42)
  • Ms. Winfrey: “But they do have side effects?” (36:46)
  • Dr. Velazquez: “I think that they’ve gotten overhyped. Medicines have side effects, but the important part is that they’re mild to moderate in the research studies.” (36:48)
  • Dr. Butsch: “Yeah.” while nodding affirmatively in response to Dr. Velazquez (36:53)

These statements further compound the misleading minimization of the risks for both Zepbound and Mounjaro, (particularly the common adverse events), by suggesting such risks are “overhyped.” The use of phrases such as “a lot of hype” and “overhyped” when referring to risk information misleadingly undermines the risk’s importance and severity.14 These statements also minimize the risks by describing them as “mild to moderate,” when this has not been demonstrated. Similar to the guest patient who was the subject of the above conversation, a number of patients taking GLP-1s, such as Zepbound and Mounjaro, experienced adverse events, of which some were so severe that patients discontinued use of the drug. For example, according to the WARNINGS AND PRECAUTIONS section of the Zepbound and Mounjaro PIs, “Use of ZEPBOUND [and MOUNJARO] has been associated with gastrointestinal reactions, sometimes severe.” In addition, according to the ADVERSE REACTIONS section of the Zepbound PI (in pertinent part):

In ZEPBOUND clinical trials, gastrointestinal adverse reactions occurred more frequently among patients receiving ZEPBOUND (5 mg 56%, 10 mg 56%, 15 mg 56%) than placebo (30%). More patients receiving ZEPBOUND 5 mg (1.9%), ZEPBOUND 10 mg (3.3%), and ZEPBOUND 15 mg (4.3%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.5%).
. . . .
Across both trials, 4.8%, 6.3%, and 6.7% of patients treated with 5 mg, 10 mg, and 15 mg of ZEPBOUND, respectively, permanently discontinued treatment as a result of adverse reactions compared to 3.4% of patients treated with placebo.

Similarly, according to the ADVERSE REACTIONS section of the Mounjaro PI (in pertinent part, emphasis added):

In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving MOUNJARO than placebo (placebo 20.4%, MOUNJARO 5mg 37.1%, MOUNJARO 10 mg 39.6%, MOUNJARO 15 mg 43.6%. More patients receiving MOUNJARO 5 mg (3.0%), MOUNJARO 10 mg (5.4%), and MOUNJARO 15 mg (6.6%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.4%).

Moreover, the statement that “medicines have side effects,” coupled with the statement that GLP-1 side effects are “mild to moderate,” further downplays the serious nature of the risks associated with GLP-1s, like Zepbound and Mounjaro, by suggesting that because drugs generally have side effects, that the individual risks of GLP-1s are no more than other drugs and are therefore of little concern. There are several additional common adverse reactions, some of which were severe in nature (e.g., hypoglycemia), that were also observed with both Zepbound and Mounjaro; but, as noted above, were omitted entirely from the video. Therefore, it is misleading to represent that the side effects of GLP-1s, like Zepbound and Mounjaro, are “mild to moderate.”

The video not only omits several serious and significant risks, it also understates the safety profile of these drugs. By essentially suggesting that safety or tolerability issues have been “overhyped,” and by implying that these products are not associated with the serious and significant risks outlined above, the video grossly misrepresents the safety profile of Zepbound and Mounjaro. This implication is false or misleading and raises significant public health and safety concerns.

Finally, 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. As noted, the video contains numerous representations and suggestions about the benefits of Zepbound and Mounjaro, while the risk information is relegated to the end of the video and briefly discussed. Of the 42-minute video, only four minutes in total are devoted to the important shared risks associated with GLP-1s, like Zepbound and Mounjaro. Additionally, the video does not provide any signal to alert the viewer where they may be able to find additional risk information about the drugs. The overall effect of disclosing risk information in this limited manner undermines the communication of risk information and thereby misleadingly minimizes the risks associated with the use of Zepbound and Mounjaro.

Failure to Submit Under Form FDA-2253

FDA regulations require any labeling or advertising devised for promotion of the drug product to be submitted at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product. Each submission is required to be accompanied by a completed transmittal Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and is required to include a copy of the product’s current professional labeling. A 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).

Conclusion and Requested Action

For the reasons described above, the video misbrands Zepbound and Mounjaro and makes the distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1 (e)(5). In addition, these materials were not submitted at the time of initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i).

This letter notifies you of our concerns and provides you with an opportunity to address them. You should take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction. Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this 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 your plan for discontinuation of such communications, or for ceasing distribution of Zepbound and Mounjaro.

If you believe that your products are not in violation of the FD&C Act, please include in your submission to us your reasoning and any supporting information for our consideration within 15 working days from the date of receipt of this letter.

Additionally, we request that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter. The corrective communication(s) should be disseminated to the audience(s) that received the promotional communication(s) identified in the opening paragraph of this letter. We recommend that corrective communication(s) include a description of the promotional communication(s) identified in this letter, which misbrand Zepbound and Mounjaro; include a summary of the concern(s) described in this letter; and provide information to correct each of these concern(s). Corrective communication(s) should be free of promotional claims and presentations. To the extent possible, corrective communication(s) should be distributed using the same media, and generally for the same duration of time and with the same frequency as the promotional communication(s) identified in the opening paragraph of this letter.

The concerns discussed in this letter do not necessarily constitute an exhaustive list of potential violations. It is your responsibility to ensure compliance with each applicable requirement of the FD&C Act and FDA implementing regulations.

Please direct your response to the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266. A courtesy copy can be sent by facsimile to (301) 847-8444. Please refer to MA 974 and MA 832 in addition to the NDA numbers in all future correspondence relating to this particular matter. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. You are encouraged, but not required, to submit your response in eCTD format. All correspondence submitted in response to this letter should be placed under eCTD Heading 1.15.1.6. Questions related to the submission of your response letter should be emailed to CDEROPDP-RPM@fda.hhs.gov.

Sincerely,
{See appended electronic signature page}
George Tidmarsh, M.D., Ph.D.
Director
Center for Drug Evaluation and Research

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This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.
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/s/
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CARTER M BEACH
09/09/2025 05:18:14 PM
On behalf of George Tidmarsh, M.D., Ph.D

________________________________

1 Dr. W. Scott Butsch is a health care provider who serves as the Director of Obesity Medicine in the Bariatric and Metabolic Institute at Cleveland Clinic. Dr. Butsch has financial and consultancy connections to Eli Lilly. Based on currently available data, from 2017-2023, the Centers for Medicare and Medicaid Services Open Payments Data website reports that Dr. Butsch has received (b)(4) in consulting fees, grants, and other payments from Eli Lilly (https://openpaymentsdata.cms.gov/physician/1050529).

2 Dr. Amanda Velazquez is a health care provider who serves as an Assistant Professor of Medicine and Surgery and the Director of Obesity Medicine at the Center for Weight Management and Metabolic Health at Cedars-Sinai Medical Center. Dr. Velazquez has financial and consultancy connections to Eli Lilly. Based on currently available data, from 2019-2023, the Centers for Medicare and Medicaid Services Open Payments Data website reports that Dr. Velazquez has received (b)(4) in consulting fees, grants, and other payments from Eli Lilly (https://openpaymentsdata.cms.gov/physician/439627).

3 GLP-1 = Glucagon-like Peptide-1

4 At approximately 20 minutes and 46 seconds, the video includes the following prominent on-screen text: “Dr. Butsch and Dr. Velazquez consult for and receive research funding from companies making GLP-1 drugs.”

5 Rhonda Pacheco is Group Vice President of Diabetes and Obesity for Eli Lilly and Company (LLY). https://investor.lilly.com/news-releases/news-release-details/zepboundtm-tirzepatide-now-available-uspharmacies-adults-living

6 This video is available on the internet at https://abc.com/shows/an-oprah-special-shame-blame-and-theweight-loss-revolution/episode-guide/season-01/01-an-oprah-special-shame-blame-and-the-weight-lossrevolution (last accessed date September 8, 2025)

7 This information is for background purposes only and does not necessarily represent the risk information that should be included in the promotional communication(s) cited in this letter.

8 The version of the Zepbound PI referred to in this letter is dated March 2024.

9 The version of the Mounjaro PI referred to in this letter is dated July 2023.

10 FDA notes that additional advisory comments have also been sent in May and November 2024 to Lilly regarding Zepbound with same/similar concerns.

11 The entirety of this video is focused on weight loss and weight loss products, specifically GLP-1s. While diabetes is briefly mentioned, the majority of the program focuses on weight loss. Mounjaro is not FDA approved for weight loss.

12 See supra footnotes 1, 2, and 3.

13 We note that shortly after the segment on side effects, Ms. Pacheco was introduced (38:19) as Group Vice President for Eli Lilly. Although Ms. Pacheco appeared to be present during the filming of the side effects segment video, Ms. Pacheco made no additions to the limited risk information provided or corrections to the misleading representations made by the previous representatives of Eli Lilly.

14 While these and other statements made by Dr. Velazquez may be a reflection of their experience as a health care provider treating patients with GLP-1s, like Zepbound and Mounjaro, their personal experience does not support the representation in a promotional communication regarding the benefits of these drugs that the serious risks associated with Zepbound and Mounjaro have received “a lot of hype” or have been “overhyped.”

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