“Honestly, I’m quite alarmed by what we see in the US now,” Novo Nordisk President and CEO Lars Fruergaard 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.”
The FDA lists 10 deaths and 100 hospitalizations potentially associated with compounded semaglutide and 495 deaths potentially associated with unspecified forms of semaglutide. The FDA Adverse Events Reporting System (FAERS) Public Dashboard shows steadily increasing adverse events potentially associated with all forms of semaglutide, rising from 1 in 2017 to 13,269 in 2024, which is nearly double the 8,786 adverse events in 2023. In short, the FDA data does not necessarily support the claim that compounded semaglutide is any more or less safe than semaglutide produced by Novo Nordisk.
The demand for Ozempic, Wegovy, and other GLP-1 receptor agonists combined with shortages in active ingredients such as semaglutide and tirzepatide has led to a cottage industry for pharmacies making compounded versions of the drug. Compounded versions are not FDA approved, but a shortage in active ingredients allows pharmacies to sell compounded versions, which are generally available at much lower price points than the brand-name versions.
As the shortage ends, manufacturers of branded GLP-1 receptor agonists are pushing to end sales of the compounded versions, which would mean that GLP-1 receptor agonists will get exponentially more expensive (over $1,000 per month), and even unaffordable for many Americans and their health care plans. According to a KFF survey, “About half (54%) of those who report ever taking the drugs say it was difficult to afford them, including one in five (22%) who say it was ‘very difficult.’ Having insurance coverage makes little difference to patients’ perceptions of the drugs’ affordability, with similar shares of those covered by insurance saying the drugs were difficult (53%) or very difficult (23%) to afford.”
Note: The FDA warns that “safety reports submitted to FDA do not necessarily reflect a conclusion by FDA that the information in the reports constitutes an admission that the drug caused or contributed to an adverse event.”