Safety Concerns Surrounding Compounded Diabetes Drugs

Novo Nordisk reports 100 hospitalizations and 10 deaths linked to compounded copies of its diabetes drugs. The company seeks FDA action against compounding pharmacies producing these complex drugs amid safety concerns, while addressing drug shortages through expanded manufacturing and dialogue with the agency.

Novo Nordisk has reported 100 hospitalizations and 10 deaths associated with compounded copies of its popular weight-loss and diabetes drugs, the company's Chief Financial Officer Karsten Munk Knudsen announced on Wednesday. The drugmaker has been evaluating numerous compounded products available in the market, uncovering serious safety concerns alongside these alarming reports.

In response, Novo Nordisk has requested the U.S. Food and Drug Administration (FDA) to prohibit compounding pharmacies from producing imitation versions of its drugs Wegovy and Ozempic. The company argued that these medications are too intricate for compounding pharmacies to safely replicate. Despite recent improvements in supply, both drugs are still considered in shortage by the FDA.

Knudsen emphasized the company's commitment to ensuring product safety, highlighting the importance of regulatory oversight in compounded drugs. He remains hopeful that Novo Nordisk's efforts to expand manufacturing capacity and engage with the FDA will eventually remove the drugs from the shortages list, thereby limiting compounding pharmacies' ability to produce replicas.

(With inputs from agencies.)