Safety Concerns Over Compounded Diabetes Drugs Raises Regulatory Eyebrows

Novo Nordisk's CFO revealed concerns over compounded versions of its weight-loss and diabetes drugs linked to several deaths and hospitalisations. These unofficial copies, produced due to drug shortages, raise safety and regulatory issues, prompting the company to request an FDA ban on such practices.

Novo Nordisk Chief Financial Officer Karsten Munk Knudsen addressed reports on deaths and hospitalizations linked to compounded copies of their weight-loss and diabetes drugs. Compounding pharmacies in the U.S. can legally replicate brand-name medications that are in short supply, raising significant safety and regulatory concerns.

The company's popular drugs, Wegovy and Ozempic, both containing semaglutide, have been subject to shortages leading to the emergence of unregulated compounding. According to the FDA's adverse events database, there have been 10 deaths linked to compounded semaglutide, although the precise causes remain unverified, underlining the risks associated with these unapproved drug versions.

CEO Lars Fruergaard Jorgensen expressed confusion over the consumption of unregulated products in the U.S. He noted that compounded versions of the drugs were being sold outside formal supply chains, highlighting the need for more stringent oversight. Novo Nordisk has urged the FDA to prohibit the compounding of their drugs, citing complex manufacturing requirements.

(With inputs from agencies.)