At least 10 deaths and 100 hospitalizations in the United States have been linked to off-brand versions of Ozempic and Wigovy, the weight-loss drug’s maker warned Wednesday.
Novo Nordisk cited U.S. Food and Drug Administration (FDA) data on side effects for combined forms of semaglutide (the generic name for the drug sold as Ozempic and Wigovy) from 2023 onwards. The FDA website says the report has not been verified. .
The Danish drugmaker’s chief executive, Lars Fruergaard Jorgensen, said last month that semaglutide was too complex for pharmacies to copy, citing a lack of oversight in the manufacturing of the compounded drug. expressed concern about the presence of Jorgensen said he is concerned about patients being able to obtain counterfeit drugs online. Health spa or weight loss clinic.
“Honestly, I’m very alarmed by what we’re seeing in the United States right now,” Jorgensen told CNN. “Patients who believe they have a safe product and believe they are receiving semaglutide know for a fact that they are not receiving semaglutide, because there is only one type of semaglutide and that is Novo. Because it’s manufactured by Nordisk. We don’t sell it to anyone else.”
Novo Nordisk CEO Lars Fluergaard Jorgensen said he was “alarmed” by news of the death.
Chris Ratcliffe/Bloomberg via Getty Images
In the United States, compounding pharmacies are allowed to manufacture different combinations of branded drugs to address supply shortages. Wegovy and Ozempic, which cost about $1,000 for a month’s supply, have been on and off the FDA’s shortage list for years.
Ozempic and Wegovy are FDA-approved, but distribution of combined versions of semaglutide may be regulated by states.
In October, Novo Nordisk asked the FDA to ban off-brand semaglutide products, saying the active ingredient was too complex to safely manufacture at the correct dosage. The agency said it had received reports of events “potentially related to dosing errors associated with combination semaglutide injectable products that required hospitalization” and was considering Novo Nordisk’s request.
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“We’re working with the FDA and I think they’re just as concerned about the health of their patients, so I think they’re looking at things that they should consider,” Jorgensen said. “So I think it remains to be seen how exactly that will play out.”
On Wednesday, Novo Nordisk reported that Wegovy’s global sales increased 79% in the final quarter of this year compared to the same period in 2023. In the United States, Wegovy’s sales increased 22% year over year.
The company announced last month that major manufacturing investments have increased supply.
