Novo Nordisk Inc.
FDA issued a warning letter to Novo Nordisk Inc. regarding a 42-minute direct-to-consumer promotional video ('An Oprah Special: Shame, Blame, and the Weight Loss Revolution') that featured paid Novo Nordisk consultants making false or misleading claims about the safety profile of Wegovy, Ozempic, and Victoza. The video omitted critical boxed-warning risk information (including MEN 2 contraindication), downplayed serious adverse events such as pancreatitis and thyroid cancer as 'overhyped,' and characterized side effects as 'mild to moderate' contrary to clinical trial data. FDA determined the video misbrands all three drugs under the FD&C Act and demanded immediate cessation of the misleading communications, a written response within 15 working days, and a corrective advertising campaign directed at the same audience.
Flagged claims (7)
double the amount of weight loss
so-called miracle medications like Ozempic, Wegovy, Mounjaro, and Zepbound
essentially copying what our normal GLP-1 hormone does in our body, but doing it a little bit better.
I think that they've gotten overhyped. Medicines have side effects, but the important part is that they're mild to moderate in the research studies.
newer agents like GLP-1s
If anybody has a history specifically of MTC... is very, very rare. So if they do have that, we are not prescribing that medication. So, we have to be able to keep up with knowing the data, and recognizing that it's rare, but it's there and we have to always screen.
There's been a lot of hype around like pancreatitis, gallbladder complications, concerns for thyroid cancer. This has really not been shown in human studies that this is a downstream complication, and that really the risk is less than 1%.
Required actions (4)
You should take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above).
Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all other promotional communications (with the 2253 submission date) for Wegovy, Ozempic, and Victoza that contain representations such as those described above, and explaining your plan for discontinuation of such communications, or for ceasing distribution of Wegovy, Ozempic, and Victoza.
We request that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter. The corrective communication(s) should be disseminated to the audience(s) that received the promotional communication(s) identified in the opening paragraph of this letter.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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