Novo Nordisk's CEO told CNN he is "alarmed" by the risks compounded versions of semaglutide — the active ingredient in the company's diabetes drug Ozempic and weight loss drug Wegovy — are posing to users.
"Honestly, I'm quite alarmed by what we see in the U.S. right now," Lars Fruergaard Jorgensen, president and CEO of Novo Nordisk, told the news outlet Nov. 6. "Patients who believe that they're getting access to 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."
Mr. Jorgensen said copycat versions of the drugs have been linked to at least 100 hospitalizations and 10 deaths, referencing data from the FDA's adverse event reporting database. The agency did not respond to CNN's request for comment, though its website emphasizes that information in the database hasn't necessarily been verified, as reports are updated by consumers and healthcare professionals.
"While the [reporting system] contains reports on a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event," the FDA's website states.
The database does list 10 deaths among patients as potentially being linked with compounded semaglutide since 2023. It lists around 500 additional deaths with no flags on compounding.
In July, the FDA warned healthcare providers of dosing errors associated with compounded versions of semaglutide, saying it received reports of hospitalizations and adverse events tied to the issue.
Semaglutide has been on the FDA's shortage list since 2022, which has enabled compounding pharmacies and manufactures to make their own, unapproved versions of the drug. Novo Nordisk in October requested the FDA block compounding pharmacies from producing versions of the drug, saying semaglutide is too complex for others to replicate safely.
The FDA is reviewing the request and has repeatedly emphasized that there are risks associated with compounded drugs.
Over the past year, Novo Nordisk and Eli Lilly — which makes diabetes and weight loss drugs Mounjaro and Zepbound — have filed multiple lawsuits against medical spas, weight loss clinics and pharmacies, accusing them of selling illegal versions that contain "impurities."