Novo Nordisk CFO, Karsten Munk Knudsen, reported concerns over safety issues linked to compounded generic versions of their diabetes and weight loss drug, semaglutide. Reports indicate 10 deaths and 100 hospitalizations have occurred among users of these compounded medications. Semaglutide, known for its effectiveness in treating type 2 diabetes and aiding weight loss, remains in high demand, leading to a shortage as marked by the FDA.
To meet demand, some companies have been creating compounded versions by altering drug compositions, a practice allowed under U.S. regulations intended to increase drug accessibility and affordability. However, these versions have raised safety concerns. According to Knudsen, Novo Nordisk's research on these compounded products indicates potential safety issues, including reports of hospitalizations and deaths.
The FDA's adverse event database shows 10 deaths associated with compounded semaglutide in the last two years, though direct causation has not been established. Novo Nordisk recently requested the FDA to include semaglutide on the "difficult-to-compound" list. CEO Lars Fruergaard Jorgensen criticized the availability of unregulated products in the U.S., predicting eventual changes over time. These products often reach consumers through online platforms and unofficial channels, such as wellness spas, bypassing legitimate supply chains.
Knudsen emphasized the need for major investments in manufacturing capacity to improve drug accessibility. Overcoming the shortage of semaglutide is challenging, and Novo Nordisk plans to continue discussions with the FDA. Knudsen noted that if semaglutide is not on the shortage list, the production of compounded versions would face restrictions, highlighting the importance of ongoing communication with the FDA.
