Drugs

FDA DTC Push Cites GLP-1 Drugs in 4 Letters

FDA’s ongoing crack down (see earlier story) on drug direct-to-consumer (DTC) promotional activities has led to three just-released Warning Letters to Eli Lilly and one to Novo Nordisk that cite the companies for their alleged violative claims about GLP-1 receptor agonists.

In the first Lilly letter, the agency takes issue with a 2024 DTC video titled “An Oprah Special: Shame, Blame, and the Weight Loss Revolution” that promoted Zepbound (tirzepatide) and Mounjaro (tirzepatide) because it creates a misleading impression about the products’ safety. The letter says several warnings and precautions associated with Zepbound and Mounjaro are 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…,” it says.

The second Lilly letter cites a DTC online video of a reporter asking company representatives about Zepbound while omitting risks associated with the drug. The video also “fails to provide material information about the consequences that may result from the use of Zepbound and creates a misleading impression about the drug’s safety,” the agency says. “This omission is especially concerning from a public health perspective given the boxed warning and serious risks associated with Zepbound,” it adds.

The third Lilly letter appears to be a duplicate of the second letter but notes the video interview appeared on Fox25’s “Living Oklahoma” Web site.

The Novo Nordisk letter cited the same Oprah video as FDA’s first Lilly letter but took exception to promotional efforts for Wegovy (semaglutide), Ozempic (semaglutide) and Victoza (liraglutide) by Novo Nordisk representatives that omit “important risk information and otherwise minimizes the risks of these drug products.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome