Eli Lilly, the pharmaceutical company, has issued an open letter addressing the misuse of its FDA-approved tirzepatide medicines, Mounjaro and Zepbound, for cosmetic weight loss. The company emphasizes that these drugs are intended for the treatment of serious diseases, not for cosmetic purposes.
Mounjaro is indicated to improve glycemic control in adults with type 2 diabetes mellitus, while Zepbound is intended for adults with obesity or those who are overweight and have at least one weight-related additional condition. Both drugs should only be used when prescribed by a licensed healthcare professional.
Eli Lilly has also expressed concern about the safety risks of using compounded tirzepatide, which are products claiming to contain tirzepatide, Mounjaro, or Zepbound that are made and/or distributed by compounding pharmacies. These products have not been reviewed by the FDA or global regulatory agencies for safety, quality, or efficacy, and may expose patients to potentially serious health risks.
The company has initiated legal action against certain medical spas, wellness centers, and compounding pharmacies that are making and/or selling products claiming to contain the active pharmaceutical ingredient (API) for tirzepatide. The goal of these lawsuits is to protect patients from the unlawful marketing, sale, distribution, and importation of non-FDA approved compounded tirzepatide products.
Eli Lilly urges patients and healthcare providers to report counterfeit ("fake") Mounjaro and Zepbound products to the Lilly Answers Center. The company remains committed to patient safety and encourages healthcare providers to review the Instructions for Use that accompany Mounjaro and Zepbound, as well as the important information about the drugs' risks contained in the Full Prescribing Information and Medication Guide for both medications.
As someone who has been prescribed Mounjaro for the treatment of type 2 diabetes, I can personally attest to the importance of using this medication as directed by a healthcare professional. I have not experienced any side effects or issues since I started using Mounjaro, and I strongly advise against the misuse of such medications for non-prescribed purposes, such as cosmetic weight loss. It's crucial to remember that these are serious medications intended for the treatment of serious health conditions, and their misuse can lead to potentially severe health risks.
Frequently Asked Questions
What specific legal actions has Eli Lilly taken against unauthorized sellers, and what has been the outcome of these actions?
Eli Lilly has initiated legal actions against various entities, including medical spas, wellness centers, and compounding pharmacies, for making and/or selling products that falsely claim to contain the active pharmaceutical ingredient (API) for tirzepatide. These lawsuits target the unlawful marketing, sale, distribution, and importation of non-FDA approved compounded tirzepatide products. The company's goal with these legal actions is to protect patients from potentially serious health risks associated with these unauthorized products. Eli Lilly is committed to considering all available legal remedies against these actors to enforce its policies and ensure patient safety.
Are there any ongoing studies or research to potentially approve tirzepatide for cosmetic use in the future?
There are no ongoing studies or research specifically aimed at approving tirzepatide (Mounjaro and Zepbound) for cosmetic use in the future. Eli Lilly's stance, as outlined in the document, is firmly against the use of its tirzepatide medicines for cosmetic weight loss. The company emphasizes that Mounjaro and Zepbound are intended for the treatment of serious diseases, such as type 2 diabetes mellitus and obesity or overweight with at least one weight-related additional condition, and not for cosmetic purposes.
How does Eli Lilly plan to enforce its policies against the misuse of tirzepatide more effectively, beyond legal action and urging reporting?
Beyond taking legal action, Eli Lilly urges patients and healthcare providers to report counterfeit ("fake") Mounjaro and Zepbound products to the Lilly Answers Center. This proactive approach of encouraging reporting is part of the company's broader strategy to combat the misuse of tirzepatide. Additionally, Eli Lilly emphasizes the importance of healthcare providers reviewing the Instructions for Use that accompany Mounjaro and Zepbound, as well as the important information about the drugs' risks contained in the Full Prescribing Information and Medication Guide for both medications. These measures are aimed at ensuring that the medications are prescribed and used safely, in accordance with FDA-approved indications.
Press Release (Updated June 20, 2024)
The U.S. Food and Drug Administration (FDA) has been investigating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 receptor agonists (GLP-1 RAs). These medicines are used to treat people with type 2 diabetes or to help those with obesity or overweight to lose weight. The FDA's preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions.
Over the last several months, the FDA has conducted detailed reviews of reports of suicidal thoughts or actions received in the FDA Adverse Event Reporting System (FAERS). The information provided was often limited and these events can be influenced by other potential factors, leading the FDA to determine that the information in these reports did not demonstrate a clear relationship with the use of GLP-1 RAs.
Similarly, the FDA's reviews of the clinical trials, including large outcome studies and observational studies, did not find an association between use of GLP-1 RAs and the occurrence of suicidal thoughts or actions. However, due to the small number of suicidal thoughts or actions observed in both people using GLP-1 RAs and in the comparative control groups, the FDA cannot definitively rule out that a small risk may exist. Therefore, the FDA is continuing to investigate this issue.
Additional evaluations include a meta-analysis of clinical trials across all GLP-1 RA products and an analysis of postmarketing data in the Sentinel System, a large data network that contains health insurance claims and patient health records that can be used to investigate safety questions about FDA-regulated products.
The FDA will communicate its final conclusions and recommendations after it completes its review or has more information to share. In the meantime, patients should not stop taking GLP-1 RAs without first consulting their health care professional, as stopping these medicines may worsen their condition. Patients are advised to report new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior to their health care professional.
The list of GLP-1 RAs (glucagon-like peptide-1 receptor agonists) approved by the FDA includes:
Hello, fellow type 2 diabetics and fitness aficionados! I'm excited to share an upcoming event that combines our love for data, health, and community involvement. The 5K@EASD Virtual Run/Walk for Diabetes Awareness is back for 2024, and I'm inviting you all to join this global movement.
What is the 5K@EASD?
The 5K@EASD is a virtual challenge that brings together people across the globe to emphasize the need for increased physical activity to help prevent diabetes and its complications. This event is not just about running or walking; it's about raising awareness and understanding of diabetes, a condition that affects millions of people worldwide.
Why Should You Participate?
Participating in the 5K@EASD is a great way to contribute to a global cause while staying active. The event is free and open to everyone, regardless of fitness level. You can run or walk the 5K from any location you choose, making it a flexible option for those with busy schedules.
Moreover, the event is a fantastic opportunity to learn more about diabetes, a chronic disease that affects many people worldwide. By participating, you're helping to raise awareness about the importance of a healthy lifestyle in preventing and controlling diabetes.
Event Details
The 5K@EASD Virtual Run/Walk for Diabetes Awareness 2024 will take place from September 7, 2024, through September 11, 2024. Registration opens in July 2024, so mark your calendars!
How to Make the Most of Your Virtual Run/Walk
Participating in a virtual event can be a unique and rewarding experience. Here are some tips to make the most of your 5K@EASD:
Join the Movement
The 5K@EASD is more than just a virtual run/walk. It's a global movement aimed at raising awareness about diabetes and the importance of physical activity in preventing and managing the disease. So, whether you're a seasoned runner or a beginner, I invite you to join the 5K@EASD Virtual Run/Walk for Diabetes Awareness 2024. Let's run, walk, and make a difference together!
Frequently Asked Questions
Are there any specific requirements or equipment needed to participate in the 5K@EASD Virtual Run/Walk?
No. Participants only need a way to track their time and distance. I did the 2023 5K@EASD on a treadmill at the gym to avoid interruptions and easily track my progress. When I finished, I took a photo of the time and distance the treadmill recorded and used that to record my results.
How will the event track participant progress and verify completion of the 5K?
Participants track their time and distance, then submit the results at the 5K@EASD website.
Are there any incentives or rewards for participants who complete the virtual run/walk?
Participants are provided personalized digital bibs when they register and finisher certificates when they upload their results.
Dexcom, a leader in diabetes care technology, has announced the upcoming launch of Stelo, a new continuous glucose monitor (CGM) tailored for individuals with type 2 diabetes who do not use insulin. This innovative product is expected to hit the U.S. market in the summer of 2024, marking a significant step forward in the management of type 2 diabetes.
Understanding Stelo
Stelo is based on Dexcom's advanced G7 CGM system but comes with custom software features designed to meet the specific needs of non-insulin-using type 2 diabetics. Unlike the G7 series, which includes alerts and alarms for more intensive insulin management, Stelo focuses on providing a simplified experience for its users.
The device boasts a 15-day sensor wear time, offering convenience and reducing the frequency of sensor changes. Initially, Stelo will be available as a cash-pay product, with Dexcom aiming to make it competitive in the market and eventually seeking insurance reimbursement.
The Importance of Glucose Monitoring
For those managing type 2 diabetes without insulin, understanding and tracking glucose levels is crucial. It provides insights into how lifestyle factors such as diet, exercise, sleep, and stress influence metabolic health. Stelo aims to empower users by providing real-time data to help them see the impact of these factors on their health.
Dexcom's Mission and Market Expansion
Dexcom has experienced significant growth, with a 24% increase in revenue in 2023 and an anticipated 16% to 21% growth in 2024, partly driven by the introduction of Stelo and further international expansion. The company's mission is to simplify and improve diabetes management globally by listening to the needs of users, caregivers, and providers.
Conclusion
Dexcom's Stelo represents a significant innovation in the field of diabetes care, specifically catering to the needs of type 2 diabetics who do not use insulin. With its user-friendly design and focus on lifestyle management, Stelo is poised to become an essential tool for many in controlling their diabetes and improving their overall health. Keep an eye out for its launch in the summer of 2024 and the potential it has to transform diabetes care.
Frequently Asked Questions
How much will Dexcom's Stelo cost for consumers, and will it be covered by insurance plans?
Dexcom's Stelo will be launched as a cash-pay product initially, with the company planning to seek insurance reimbursement eventually. While a specific price was not mentioned, Dexcom aims to be competitive with a competitor's cash price of $800 to $900 per year. This indicates that Dexcom is aware of the market standards and is aiming to position Stelo as an affordable option for users. The company has also demonstrated with United Healthcare and Intermountain Health that its CGM can save $400 to $500 per month in this patient group, suggesting potential cost benefits that could influence insurance coverage decisions in the future.
How accurate is the Stelo CGM compared to other CGMs on the market, and does it require any calibration?
While the specific accuracy details of Stelo were not provided in the search results, information about Dexcom's G6 model can offer some insights. The Dexcom G6 does not require calibration, but users have the option to calibrate if they notice discrepancies between the CGM readings and fingerstick meter numbers. This calibration process is designed to bring the CGM readings closer to meter values. Given that Stelo is based on the G7 platform, which is an evolution of the G6, it's reasonable to infer that Stelo might offer similar accuracy and calibration features. However, specific details about Stelo's accuracy and whether it requires or allows for calibration were not directly addressed in the provided results.
Is Dexcom's Stelo compatible with other health management devices or apps, such as fitness trackers or dietary logging apps?
Stelo's compatibility with other health management devices or apps has yet to be addressed. However, Dexcom's G6 model is compatible with a variety of iOS and Android smart devices, suggesting that Dexcom values interoperability and user convenience. Given this precedent, it's plausible that Stelo will also support integration with smart devices, potentially extending to health and fitness apps to offer a comprehensive health management ecosystem. However, specific details about which devices or apps Stelo will be compatible with are not available at this time.
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