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Compounded variations of semaglutide, the energetic ingredient in authorized diabetes and weight problems medication Ozempic and Wegovy, have been related to at the least 100 hospitalizations and 10 deaths, the chief government of Ozempic maker Novo Nordisk warned Wednesday.
“Actually, I’m fairly alarmed by what we see within the US now,” Novo Nordisk President and CEO Lars Fruergaard Jorgensen informed CNN. “Sufferers who imagine that they’re having access to a protected product, they usually imagine they’re getting semaglutide … I do know for a indisputable fact that they aren’t getting semaglutide, as a result of there’s just one semaglutide, and that’s produced by Novo Nordisk, and we don’t promote that to others.”
Novo Nordisk mentioned the information on 10 deaths and greater than 100 hospitalizations got here from the US Meals and Drug Administration’s opposed occasion reporting database for semaglutide; the FDA warns that the studies in that system aren’t verified and don’t imply the medication have precipitated the harms documented. The company didn’t instantly reply to a request for touch upon the studies.
Compounded medication are made by pharmacies or producers aside from the businesses that make FDA-approved variations of the medicines, they usually usually are allowed when medication are in scarcity.
Semaglutide and the same compound, tirzepatide, had been on the FDA’s shortages record since 2022, and the recognition of the medicines, in a category often called GLP-1 receptor agonists, led to entire businesses constructed on compounded variations.
The drug producers, in addition to some docs and the FDA, have warned that compounded variations may be dangerous as a result of they’re not regulated as carefully and aren’t FDA-approved.
The FDA said in October that it had acquired “a number of studies of opposed occasions, some requiring hospitalization, that could be associated to dosing errors related to compounded injectable semaglutide merchandise.”
The company additionally warned that some compounders could also be promoting salt types of semaglutide, that are totally different energetic elements than are within the authorized medication, and that counterfeit types of Ozempic are being bought.
Final month, the FDA mentioned the scarcity of tirzepatide, bought by Eli Lilly as Mounjaro for diabetes and Zepbound for weight problems, had been resolved, which was anticipated to result in the top of mass compounding of the drugs. However the company said later it was re-evaluating the choice that the scarcity is over amid litigation, placing compounding of tirzepatide right into a grey space.
In the meantime, semaglutide stays on the shortages record, however Novo Nordisk hopes it received’t be for lengthy. The corporate final week famous that the final remaining dose briefly provide, the bottom dose of Wegovy, is now listed as obtainable.
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“We’re collaborating with the FDA, and I feel they’re trying into what are a few of the issues they need to make, as a result of I feel they’re equally involved concerning the well being of sufferers,” Jorgensen mentioned. “So precisely how that may play out, I feel, nonetheless stays to be seen.”
The FDA informed CNN final week that it’s “presently working to find out whether or not the demand or projected demand for semaglutide inside the USA exceeds the obtainable provide.”
The company’s opposed occasion database for semaglutide reveals 10 deaths amongst sufferers probably related to compounded semaglutide since 2023. It additionally lists virtually 500 further deaths for semaglutide not flagged as being associated to compounding.
The FDA notes that there are limitations to the information, together with that whereas the database “comprises studies on a specific drug or biologic, this doesn’t imply that the drug or biologic precipitated the opposed occasion” — which means deaths could also be unrelated to the drug. The studies are offered by customers and health-care professionals, the company says, and the data hasn’t essentially been verified.
It additionally says there are situations of duplicative studies within the system and people with incomplete data.