Compounded versions of semaglutide, the active ingredient in approved diabetes and obesity drugs Ozempic and Wegovy, have been associated with at least 100 hospitalizations and 10 deaths, the chief executive of Ozempic maker Novo Nordisk warned Wednesday.
Novo Nordisk said the 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 warns that the reports in that system aren’t verified and don’t mean the drugs have caused the harms documented. The agency didn’t immediately respond to a request for comment on the reports.
Compounded drugs are made by pharmacies or manufacturers other than the companies that make FDA-approved versions of the medicines, and they typically are allowed when drugs are in shortage.
Semaglutide and a similar compound, tirzepatide, had been on the FDA’s shortages list since 2022, and the popularity of the medicines, in a class known as GLP-1 receptor agonists, led to entire businesses built on compounded versions.
The drug manufacturers, as well as some doctors and the FDA, have warned that compounded versions can be risky because they’re not regulated as closely and are not FDA-approved.
The FDA 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 agency also warned that some compounders may be selling salt forms of semaglutide, which are different active ingredients than are in the approved drugs, and that counterfeit forms of Ozempic are being sold.
Last month, the FDA said the shortage of tirzepatide, sold by Eli Lilly as Mounjaro for diabetes and Zepbound for obesity, had been resolved, which was expected to lead to the end of mass compounding of the medicine. But the agency said later it was re-evaluating the decision that the shortage is over amid litigation, putting compounding of tirzepatide into a gray area.
Meanwhile, semaglutide remains on the shortages list, but Novo Nordisk hopes it won’t be for long. The company last week noted that the last remaining dose in short supply, the lowest dose of Wegovy, is now listed as available.
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“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.”
The agency’s adverse event database for semaglutide shows 10 deaths among patients potentially associated with compounded semaglutide since 2023. It also lists almost 500 additional deaths for semaglutide not flagged as being related to compounding.
The FDA notes that there are limitations to the data, including that while the database “contains reports on a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event” — meaning deaths may be unrelated to the drug. The reports are provided by consumers and health-care professionals, the agency says, and the information hasn’t necessarily been verified.
It also says there are instances of duplicative reports in the system and those with incomplete information.