THURSDAY, Nov. 7, 2024 (HealthDay News) -- The head of the company that makes the diabetes and obesity drugs Ozempic and Wegovy has warned that compounded versions of the active ingredient in those medications have now been linked to at least 100 hospitalizations and 10 deaths.
“Honestly, I’m quite alarmed by what we see in the U.S. now,” Novo Nordisk President and CEO Lars Fruergaard Jorgensen told CNN on Wednesday. “Patients who believe that they’re getting access to a safe product, and they believe they’re getting semaglutide … I know for a fact that they are not getting semaglutide, because there’s only one semaglutide, and that’s produced by Novo Nordisk, and we don’t sell that to others.”
Compounded drugs are made by pharmacies or manufacturers other than the companies that make approved versions of those medicines, and they typically are allowed when there is a shortage of those drugs.
Semaglutide, and other GLP-1 drugs like it, have experienced shortages in the past two years as millions of Americans have turned to the medications for help with significant weight loss.
While semaglutide remains on the shortage list, Novo Nordisk noted last week that the last remaining dose in short supply -- the lowest dose of Wegovy -- is now listed as available, CNN reported.
“We’re collaborating with the FDA, and I think they’re looking into what are some of the considerations they have to make, because I think they’re equally concerned about the health of patients,” Jorgensen said. “So exactly how that will play out, I think, still remains to be seen.”
Where did the troubling statistics on deaths and hospitalizations surface? They came from the U.S. Food and Drug Administration’s adverse event reporting database for semaglutide.
However, the FDA warns that reports in that database aren’t yet verified and don’t mean the drugs have actually caused the harms reported. The agency didn’t respond to a request for comment on the reports.
Still, the agency said in October that it had received “multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors associated with compounded injectable semaglutide products.”
The FDA has also warned that some compounders may be selling salt forms of semaglutide, which contain different active ingredients, and that counterfeit forms of Ozempic are being sold.
Semaglutide and a similar GLP-1 drug, tirzepatide (Mounjaro/Zepbound), had been on the FDA’s shortages list since 2022, as the popularity of the medicines, known as GLP-1 receptor agonists, soared.
Last month, the FDA said the shortage of tirzepatide had been resolved, but the agency later posted it was re-evaluating that decision amid litigation.
Meanwhile, the FDA told CNN last week that it’s “currently working to determine whether the demand or projected demand for semaglutide within the United States exceeds the available supply.”
More information
The FDA has more on the dangers of compounded GLP-1 drugs.
SOURCE: CNN
