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Combined versions of semaglutide, the active ingredient in the approved diabetes and obesity drugs Ozempic and Wegovy, have caused at least 100 hospitalizations and 10 deaths, the CEO of Ozempic maker Novo Nordisk warned Wednesday.
“I'm honestly shocked by what we're seeing in the U.S. right now,” Novo Nordisk President and CEO Lars Førregaard Jørgensen told . “Patients who believe they're getting a safe product and they're getting semaglutide … I know for sure they're not taking semaglutide, because there's only one semaglutide, and that's made by Novo Nordisk, and we don't sell it to others.”
Novo Nordisk said the data on 10 deaths and more than 100 hospitalizations came from an adverse event report by the US Food and Drug Administration. database for semaglutide; The FDA cautions that the reports in that system are unverified and do not mean the drugs caused the reported harms. The agency did not immediately respond to a request for comment on the reports.
Compounded drugs are made by pharmacies or manufacturers other than companies that make FDA-approved versions of drugs, and are typically approved when drugs are in short supply.
Semaglutide and the same mixture, TirzepatideIn the year It has been on the FDA's shortage list since 2022, and the popularity of the drugs, in a class known as GLP-1 receptor agonists, Complete businesses Built on combined versions.
The drug manufacturers, as well as some doctors and the FDA, have warned that compounded versions could be dangerous because they are not closely regulated and not approved by the FDA.
FDA he said. In October, “several reports of adverse events, some requiring hospitalization, may be related to dosing errors associated with compounded semaglutide products.”
The agency also warned that some compounds may be selling semaglutide salt forms, which are different active ingredients than the approved drug, and false forms of Ozympic are being sold.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, which represents compounding pharmacies, said in a statement. Post “When adverse events occur, as sometimes happens with FDA-approved drugs, legitimate compounding pharmacies operate within a compliance framework that ensures patient safety is paramount and necessary for the pharmacy to continue serving its patients,” he said on LinkedIn.
Last month, the FDA announced that shortages of tirzepatide, sold by Eli Lilly's Mounjaro for diabetes and obesity drug Zepbound, have been resolved, which is expected to end mass production of the drug. But the agency he said. He was later reconsidering the decision, which put the tirzepatide formulation into a gray area and the shortage ended amid litigation.
Meanwhile, semaglutide remains on the shortage list, but Novo Nordisk hopes it won't last long. The company said last week that the last remaining amount in short supply, the lowest amount of Wegovy, is now listed.
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“We're working with the FDA, and I think they're looking at what some of the comments are that they should take because I think they're equally concerned about the health of patients,” Jorgensen said. “So how exactly that will play out, I think, remains to be seen.”
The FDA told last week that it is “currently working to determine whether the current demand or projected demand for semaglutide in the United States exceeds the supply.”
An adverse event of the agency Database For semaglutide, it shows 10 deaths among patients treated with compounded semaglutide since 2023. Additionally, approximately 500 additional semaglutide deaths were not attributed to the combination.
FDA Notes There are limitations to the data, including that the database “reports on a particular drug or biological, this does not mean that the drug or biological caused an adverse event” – that is, the death may not be related to the drug. The reports are submitted by consumers and health care professionals, the agency says, and the information is not necessarily verified.
It also says there are instances of duplicate reports and incomplete data in the system.