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Location: Indianapolis, IndianaWarning Letter Date: September 9, 2025FDA Department Issuing Warning: Center for Drug Evaluation and Research (CDER)Type of Warning: False & Misleading Claims/Misbranded DrugsSubject of Violation: An Oprah Special: Shame, Blame, and the Weight Loss Revolution, regarding Zepbound (tirzepatide) and Mounjaro (tirzepatide)FDA Warning: In the program, which aired on television in 2024 and until recently was available continuously on the ABC website and through various streaming services, Eli Lilly promoted Mounjaro and Zepbound in a manner that failed to present the serious risks of these drug products in a truthful and nonmisleading manner, despite FDAs prior correspondence (advisory comments dated June 13, 2022 and June 21, 2022)
Reduced metabolic stress: Lower weight, improved insulin sensitivity, and better glucose control reduce the metabolic burden on organs that are damaged by diabetes
Inside, youll learn: Defining features of DTC care models, including virtual intake and online prescribing Key risks and limitations of the DTC care model, particularly for GLP-1 RA and GIP/GLP-1 RA prescriptions A comparison of medication adherence rate and out-of-pocket (OOP) costs between DTC models and integrated specialty pharmacy care Discover how integrated specialty pharmacy care drives better access, affordability, and adherence.