On November 6, Novo Nordisk's Chief Financial Officer, Karsten Munk Knudsen, stated that the company had learned that 100 people were hospitalized and 10 people died after taking generic combination drugs of its bestselling weight loss and diabetes medications.
Lars Fruergaard Jorgensen, shown testifying on Capitol Hill in September, is warning about potential risks from compounded versions of the drug semaglutide. Image source: CNN News
Currently, Novo Nordisk has requested that the U.S. Food and Drug Administration (FDA) ban the manufacturing of generic versions of Wegovy and Ozempic, citing that these two drugs are too complex for pharmaceutical companies to replicate safely. The company issued a warning regarding this matter.
Knudsen mentioned that the company has been monitoring "some of the combination formulations on the market and has identified multiple safety issues," as well as reports of hospitalization and death.
U.S. regulations allow pharmaceutical companies to replicate brand-name drugs that are in short supply by combining, mixing, or altering the drug's components to meet demand. Both Wegovy and Ozempic contain the active ingredient semaglutide, and these medications are in short supply in the U.S.
Although all dosages of Ozempic and Wegovy are currently listed as "available" on the FDA's website, these drugs remain on the agency's shortage list.
At that time, Novo Nordisk stated that this was the result of significant investments to expand production capacity and "ongoing communication" with the FDA.
Regarding this issue, Knudsen said, "I don't want to speculate today on whether we have completely removed ourselves from the shortage list, but we hope to do so in the future. If a product is not in short supply, the production of generics by pharmaceutical companies will be restricted. Novo Nordisk is 'highly concerned with product safety,' and as a result, the company is very focused on combination products in the market and related safety concerns."