来源：FDA官网① Novo Nordisk's Chief Financial Officer stated that 10 people have died after taking the compound generic weight loss drug, with another 100 hospitalized. ② Novo Nordisk has requested the FDA to include semaglutide on the 'Demonstrably Difficult to Synthesize List' to restrict generic production, and the company will continue dialogue with the FDA to address pharmaceutical accessibility issues.
Caixin Media News on November 7 (Editor Zhao Hao), Novo Nordisk's Chief Financial Officer Karsten Munk Knudsen said on Wednesday (November 6) that the company has learned that 10 people have died after taking the compound generic weight loss drug, with another 100 hospitalized.
Semaglutide developed by Novo Nordisk is outstanding in treating type 2 diabetes and as a weight loss drug. Due to high demand, semaglutide is currently marked as in short supply by the US Food and Drug Administration (FDA).
Source: FDA Official Website
In order to meet market demand, compound pharmaceutical companies and pharmacies replicate this popular weight loss drug through combining, mixing, or altering drug components. This is allowed by US regulations, and there are indeed laws in the USA that promote this competition, improve pharmaceutical accessibility, and lower prices.
However, the downsides are also evident. Knudsen stated at a media briefing that the company has been researching some compound products in the market and found many safety issues, as well as reports of hospitalization and deaths.
According to the FDA's adverse event database, there have been 10 death cases related to compound semaglutide in the past two years, however, causes have not been determined. It is worth noting that FDA reports cannot prove that a potential health hazard event was caused by a certain medication.
Last month, Novo Nordisk requested the FDA to include semaglutide in the 'Demonstrably Difficult to Synthesize' list. The company's CEO Lars Fruergaard Jorgensen stated that it is baffling that Americans can inject themselves with a product that is unregulated, unapproved, or uninspected.
"This is very confusing to me." But Zhou Fude believes that "this situation will change over time." He mentioned that these generic drugs are sold online and in some so-called 'wellness spas', without a proper supply chain.
Knudsen, chief financial officer of Novo-Nordisk, stated that pharmaceutical accessibility should be expanded through significant investments in expanding manufacturing capacity. He pointed out that it is difficult for semaglutide to immediately overcome the supply shortage, and the company will continue to engage with the FDA.
Knudsen stated that if semaglutide is not on the shortage list, there will be limitations on pharmacies producing generic versions. Therefore, it is important to maintain communication with the FDA.
