FDA sends Novo Nordisk warning letter over weight loss video

The FDA posted a warning letter sent to Novo Nordisk (NVO) over a weight loss video the agency deems “false or misleading.” The letter states, “The video misbrands Wegovy, Ozempic, and Victoza within the meaning of the Federal Food, Drug and Cosmetic Act and makes its distribution violative. In addition, these materials were not submitted at the time of initial dissemination or publication as required…These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the safety of Wegovy, Ozempic, and Victoza, which are drugs with multiple serious, potentially life-threatening 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 nonmisleading information regarding the serious risks associated with the use of a weight management prescription drug product, such as Wegovy, and with the use of type 2 diabetes prescription drug products, such as Ozempic and Victoza.”