Combined semaglutide associated with at least 10 deaths, the CEO of Novo Nordisk warns | CNN

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Semaglutide, which is the active ingredient of the approved diabetes and obesity drugs, Ozempic and Wegovy, is associated with at least 100 people sleeping and 10 people, the chief executive of the manufacturer of Ozempic Novo Nordisk warned Wednesday.

“Honestly, I’m very alarmed by what we’re seeing in the US right now,” Novo Nordisk President and CEO Lars Fruergaard Jorgensen told CNN. “Patients who believe they’re getting a safe product, and they believe they’re getting semaglutide… I know they’re not getting semaglutide, because there’s only one semaglutide, and it’s produced by Novo Nordisk, and we don’t sell that to others.”

Novo Nordisk said data on 10 deaths and more than 100 hospitalizations came from the US Food and Drug Administration’s adverse event reporting database for semaglutide; The FDA cautions that the reports in the system have not been verified and do not mean that the drugs caused the reported injuries. 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 types of drugs, and are often prescribed when drugs are in short supply.

Semaglutide and a similar compound, tirzepatide, have been on the FDA’s shortage list since 2022, and the popularity of the drugs, in the group known as GLP-1 receptor agonists, has led to entire businesses built on the combination .

Drug makers, along with some doctors and the FDA, have warned that compounded versions can be dangerous because they are not closely regulated and not approved by the FDA.

The FDA said in October that it had received “numerous reports of adverse events, some requiring hospitalization, that may be related to dosing errors associated with semaglutide combination products.”

The agency also warned that some chemists may be selling salt forms of semaglutide, which are different active ingredients than the approved drug, and that counterfeit Ozempic is being sold.

Last month, the FDA said that the shortage of tirzepatide, marketed by Eli Lilly as Mounjaro for diabetes and Zepbound for obesity, had been resolved, which was expected to lead to the end of the bulk drug mix. But the agency said later it was reevaluating the decision that the shortage had ended among the cases, putting the tirzepatide compound in a gray area.

Meanwhile, semaglutide is still on the shortage list, but Novo Nordisk hopes it won’t be for long. The company last week noted that the last remaining missing balance, the lowest Wegovy balance, has been listed as available.

“We’re cooperating with the FDA, and I think they’re looking at other things that they need to do, because I think they’re equally concerned about the health of patients,” Jorgensen said. “Exactly how that will play out, I think remains to be seen.”

The FDA told CNN last week that it is “currently working to determine whether the demand or anticipated demand for semaglutide in the United States exceeds the available supply.”

The semaglutide center’s adverse event database shows 10 deaths among patients that may be associated with combined semaglutide from 2023. It also lists approximately 500 additional deaths for non-semaglutide marked as related to integration.

The FDA notes that there are limitations in the data, including that although the database “contains reports on a particular drug or biologic, this does not necessarily mean that the drug or biologic caused the adverse event” — meaning that the death and it may not be drug related. The reports are provided by consumers and health professionals, the agency says, and the information has not been verified.

It also says that there are instances of repeated reports in the system and with incomplete information.