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)
Deficiency in vitamin B6 is commonly linked to malnutrition, alcoholism, malabsorption syndromes, or as an adverse effect of certain medications, such as cyclosporine, hydralazine, cycloserine, penicillamine, isoniazid, levodopa, phenelzine and chemotherapy treatments (5, 11, 16, 18)
Viltolarsen: first approval
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