Novo Nordisk CEO warns of at least 10 deaths linked to compounded semaglutide

Compounded semaglutide, the active ingredient in the diabetes and obesity treatments Ozempic and Wegovy, has been linked to over 100 hospitalizations and at least 10 deaths, according to the CEO of Ozempic maker Novo Nordisk.

Novo Nordisk President and CEO Lars Fruergaard Jorgensen expressed his concern, telling Dinogo, “It’s deeply troubling to see what's happening in the US. Patients believe they’re receiving a safe product, but they’re actually not getting semaglutide. Only Novo Nordisk produces the real semaglutide, and we do not sell it to others.”

Novo Nordisk reported that the data concerning 10 deaths and more than 100 hospitalizations was sourced from the US Food and Drug Administration's adverse event database for semaglutide. However, the FDA notes that reports in this system are unverified and do not necessarily imply causality. The agency has yet to respond to inquiries about the reports.

Compounded medications are produced by pharmacies or manufacturers other than the companies behind FDA-approved versions, typically during times of drug shortages.

Semaglutide and its counterpart, tirzepatide, have been on the FDA’s shortage list since 2022. As demand for these GLP-1 receptor agonists surged, businesses offering compounded versions of these drugs began to emerge.

Both drug makers and some doctors, along with the FDA, have raised concerns about compounded versions of these drugs, as they are not subject to the same stringent regulations and are not FDA-approved.

In October, the FDA reported receiving “multiple cases of adverse events, some requiring hospitalization,” which may have been caused by dosing errors with compounded injectable semaglutide products.

The agency also warned that some compounders might be selling semaglutide in salt forms, which differ from the approved drugs, and that counterfeit Ozempic products are being sold.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, which represents pharmacies producing compounded drugs, stated in a LinkedIn post that while adverse events can occur with both compounded and FDA-approved medications, legitimate compounding pharmacies operate under strict regulations to prioritize patient safety, which is vital for their continued service to patients.

The FDA announced last month that the shortage of tirzepatide, marketed by Eli Lilly as Mounjaro for diabetes and Zepbound for obesity, had been resolved. This was expected to end the large-scale compounding of the drug. However, the agency later stated that it was revisiting its decision, with ongoing litigation causing uncertainty around the status of the tirzepatide shortage and its compounded forms.

While semaglutide continues to be on the shortage list, Novo Nordisk is optimistic that the situation will improve soon. The company recently announced that the lowest dose of Wegovy, which had been in short supply, is now available again.

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“We are working closely with the FDA, and I believe they are considering the necessary factors because they share the same concern for patient health,” said Jorgensen. “How this will ultimately unfold, I’m not sure, but it’s still uncertain,” he added.

Last week, the FDA told Dinogo that it is currently assessing whether the demand or projected demand for semaglutide in the United States exceeds its available supply.

According to the FDA’s adverse event database for semaglutide, there have been 10 deaths possibly linked to compounded semaglutide since 2023. Additionally, nearly 500 other deaths were recorded for semaglutide, though they were not specifically flagged as related to compounding.

The FDA points out that the data has limitations, including the fact that while the database includes reports on specific drugs, this does not confirm that the drug caused the adverse event. As such, the reported deaths may not necessarily be tied to the drug itself. The reports are submitted by consumers and healthcare professionals and have not been fully verified, the agency explains.

The FDA also notes that some reports in the system may be duplicates or contain incomplete information.