Off-brand Ozempic associated with at least 10 deaths, Novo Nordisk CEO warns

(CNN) — The combination of semaglutide, the active ingredient in approved diabetes and obesity drugs Ozempic and Wigovy, has been linked to at least 100 hospitalizations and 10 deaths, Ozempic maker Novo Nor CEO Disc warned on Wednesday.

“Frankly, we are very alarmed by the situation we are seeing in the United States right now,” Lars Fluergaard Jorgensen, president and CEO of Novo Nordisk, told CNN. he said. “Patients who believe they have access to a safe product believe they are being given semaglutide…There is only one semaglutide and it is manufactured by Novo Nordisk, so if they are given semaglutide It’s true that we don’t. We don’t sell it to anyone.”

Novo Nordisk said the data on the 10 deaths and more than 100 hospitalizations came from U.S. Food and Drug Administration adverse event reports. database In the case of semaglutide. The FDA cautions that its system’s reports are unverified and do not mean the drug caused the harms described in the document. The agency did not immediately respond to a request for comment on the report.

Combination drugs are made by pharmacies or manufacturers other than the companies that make FDA-approved drugs, and are typically allowed when there is a drug shortage.

Semaglutide and similar compounds, Tirzepatidehas been on the FDA’s shortage list since 2022, due to the popularity of a class of drugs known as GLP-1 receptor agonists. whole business Built on composite version.

Pharmaceutical companies, some doctors and the FDA have warned that the combined form is less tightly regulated and not FDA-approved and may pose risks.

F.D.A. said In October, the company announced that it had received “multiple reports of adverse events (some requiring hospitalization) that may be related to dosing errors associated with combined semaglutide injections.”

The agency also warned that some compounders may be selling the salt form of semaglutide, a different active ingredient than the one contained in the approved drug, and that counterfeit versions of Ozempic are being sold. .

Last month, the FDA announced that a shortage of tirzepatide, sold by Eli Lilly as Munjaro for diabetes and Zepbound for obesity, had been resolved, a move expected to lead to an end to the drug’s mass combination use. Ta. But the agency said It later reevaluated its decision to eliminate the shortage amid litigation and placed the formulation of tirzepatide in a gray area.

Meanwhile, semaglutide remains on the shortage list, but Novo Nordisk hopes that won’t be the case for long. The company said last week that the last remaining missing doses, or the lowest dose, Wegoby, were listed as available.

“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.”

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

Government Adverse Events database The report on semaglutide shows that since 2023, there have been 10 deaths in patients potentially associated with compounded semaglutide. It also lists approximately 500 additional deaths from semaglutide that were not flagged as combination-related.

F.D.A. memo There are limitations to the data, including that the database “contains reports about a particular drug or biologic, but this does not mean that the drug or biologic caused an adverse event,” i.e. This means that the death may be unrelated to the drug. The agency said the reports were provided by consumers and medical professionals, and the information was not necessarily verified.

There are also instances of duplicate reports or reports containing incomplete information in the system.

CNN Wire
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