At least ten deaths and 100 hospitalizations have been linked to off-brand versions Ozempic and Wegovy in the US, the manufacturer of the weight-loss drugs warned on Wednesday.
Novo Nordisk cited data from the US Food and Drug Administration (FDA) on adverse reactions to compounded versions of semaglutide — the generic name for the drug marketed as Ozempic and Wegovy — since 2023. The reports have not been verified, according to the FDA’s website.
Lars Fruergaard Jorgensen, the Danish pharmaceutical company’s chief executive, raised concerns about lacking oversight in the production of the compounded drugs, following statements last month that semaglutide is too complex to be copied by compounding pharmacies. Jorgensen said it was concerning that patients could obtain the copycat drugs online, and from health spas or weight-loss clinics.
“Honestly, I’m quite alarmed by what we see in the US now,” Jorgensen told CNN. “Patients who believe that they’re getting access to a 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.”
In the US, compounding pharmacies are allowed to produce altered combinations of brand-name drugs to address supply shortages. Wegovy and Ozempic, which cost about $1,000 for a one-month supply, have been on and off the FDA’s shortage list for years.
While Ozempic and Wegovy are FDA-approved, the distribution of compounded versions of semaglutide is sometimes regulated by the states.
In October, Novo Nordisk asked the FDA to ban off-brand semaglutide products, arguing that the active ingredient was too complex to manufacture safely in the correct dosages.
The agency said it had received reports of events “requiring hospitalization, that may be related to dosing errors associated with compounded injectable semaglutide products”, and that it was reviewing Novo Nordisk’s request.
