Compounded semaglutide is linked to at least 10 deaths, Novo Nordisk CEO warns

CNN
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Compounded versions of semaglutide, the active ingredient in approved diabetes and obesity drugs Ozempic and Wegovy, have been linked to at least 100 hospitalizations and 10 deaths, the chief executive of Ozempic maker Novo Nordisk warned on Wednesday.

“Frankly, I’m quite disturbed by what we’re seeing in the US right now,” Lars Fruergaard Jorgensen, president and CEO of Novo Nordisk, told CNN. “Patients who think they’re getting access to a safe product and think they’re getting semaglutide… I know for a fact that they’re not getting semaglutide because there’s only one semaglutide, and that’s made by Novo Nordisk, and that We don’t sell to others.”

Novo Nordisk said data on 10 deaths and more than 100 hospitalizations came from the U.S. Food and Drug Administration’s adverse event reporting database for semaglutide; The FDA warns that the reports in this system are unverified and do not mean that the drugs caused the harms documented. The agency did not immediately respond to a request for comment on the reports.

Compound drugs are made by pharmacies or manufacturers that do not produce the FDA-approved versions of the drugs and are typically allowed when drugs are in short supply.

Semaglutide and a similar compound, tirzepatide, had been on the FDA’s shortlisted list since 2022, and the popularity of the drugs in a class called GLP-1 receptor agonists led to entire companies based on compounded versions.

Drug makers, as well as some doctors and the FDA, have warned that compounded versions can be risky because they are not as tightly regulated and not approved by the FDA.

The FDA said in October that it had “received multiple reports of adverse events, some of which required hospitalization and may be related to dosing errors associated with compounded semaglutide injectable products.”

The agency also warned that some manufacturers may be selling salt forms of semaglutide that have different active ingredients than those in the approved drugs, and that counterfeit forms of Ozempic are being sold.

Last month, the FDA announced that the shortage of tirzepatide, sold by Eli Lilly as Mounjaro for diabetes and Zepbound for obesity, had been resolved, likely leading to the end of mass manufacturing of the drug. But the agency later said it was reviewing the decision that the deficiency had been overcome due to litigation and assessed the composition of tirzepatide in a gray area.

Meanwhile, semaglutide remains on the shortage list, but Novo Nordisk hopes that won’t be the case for much longer. The company noted last week that the last remaining scarce dose, the lowest Wegovy dose, is now listed as available.

“We’re working with the FDA, and I think they’re looking at some of the considerations that they need to make because I think they’re equally concerned about the health of patients,” Jorgensen said. “Exactly how this will play out remains to be seen, in my opinion.”

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

The agency’s adverse event database for semaglutide shows ten patient deaths since 2023 that may be related to the composition of semaglutide. In addition, nearly 500 additional deaths are listed for semaglutide that are not flagged as being related to the composition of semaglutide.

The FDA notes that there are limitations to the data, including that while the database “contains reports of a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event” — meaning deaths may not be related to the medication. The reports come from consumers and health professionals, the agency said, and the information has not necessarily been verified.

It also says that there are cases of duplicate reports in the system and those with incomplete information.