Novo Nordisk said on Wednesday it was aware of reports of 10 deaths and 100 hospitalizations of people who had taken compounded copies of its weight-loss and diabetes drugs.
U.S. regulations allow compounding pharmacies to copy brand-name medicines in short supply by combining, mixing or altering drug ingredients to meet demand.
Novo Nordisk's popular weight-loss injection Wegovy and diabetes drug Ozempic, both known chemically as semaglutide, were — until recently — in shortage in the United States.
Given all the U.S. regulatory surveillance of Novo Nordisk's production of the two drugs, CEO Lars Fruergaard Jorgensen said it was puzzling that people in the United States could inject themselves with a product not regulated, approved or inspected.
"It beats me," he told Reuters after the company reported better-than-expected third-quarter results. "I think this is something that will change over time," he said of the oversight for compounded versions of Wegovy.
He added that the copycat versions were being sold online and through so-called "health spas" rather than through the formal supply chain where Novo Nordisk and chief rival Eli Lilly sell their approved medicines.
Last month, Novo Nordisk asked the FDA to ban compounding pharmacies from making copycat versions of Wegovy and Ozempic, which it said were too complex for those manufacturers to produce safely.
Multiple safety concerns
Earlier on Wednesday, Novo Nordisk's Chief Financial Officer Karsten Munk Knudsen told a media briefing that the company had been looking at a number of compounded products in the market and identified multiple safety concerns as well as reports of hospitalizations and deaths.
The company did not give further details when asked to elaborate on the reports and whether there was a causal link between the medication and the deaths and hospitalizations he mentioned.
Jorgensen noted that the safety reporting on compounded versions was not done through the FDA's adverse events system.
Although all dose strengths of Ozempic and Wegovy are now listed as available on the FDA website, the drugs remain on the agency's shortages list.
This was a result of significant investments to expand its manufacturing capacity and ongoing communication with the FDA, the company said at the time.
"This is an ongoing dialogue with the FDA. I don't want to speculate today whether we're completely off the shortages list, but this is a first step and we're hopeful that we'll be getting off in the future," Knudsen told the media briefing on Wednesday.
He said that was important because if a product was not on the shortages list, there were limitations for compounding pharmacies making copycat versions.
