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Novo Nordisk, a leading pharmaceutical company, has acknowledged reports of 10 deaths and 100 hospitalizations associated with compounded copies of its popular weight-loss and diabetes medications, Wegovy and Ozempic. The company's Chief Financial Officer, Karsten Munk Knudsen, revealed this information during a media briefing on Wednesday.
Key Insights:
10 deaths and 100 hospitalizations reported due to compounded copies of Wegovy and Ozempic
Novo Nordisk requests FDA ban on compounding pharmacies making copycat versions
Multiple safety concerns identified with compounded products
Regulatory loopholes allow unregulated, unapproved products to be sold online and through "health spas"
Novo Nordisk expands manufacturing capacity and engages with FDA to address shortage.
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 future
Karsten Munk Knudsen, Chief Financial Officer
Compounding Pharmacies Under Scrutiny:
The issue lies with compounding pharmacies in the US, which are allowed to create copycat versions of brand-name medicines in short supply. Wegovy and Ozempic, both containing semaglutide, were recently in shortage in the US. However, Novo Nordisk has invested significantly in expanding manufacturing capacity, and the FDA website now lists all dose strengths as available.
Safety Concerns and Regulatory Loopholes:
Novo Nordisk has identified multiple safety concerns with compounded products, prompting the company to request the FDA to ban compounding pharmacies from making copycat versions of Wegovy and Ozempic. CEO Lars Fruergaard Jorgensen expressed puzzlement over the lack of regulation, stating that it's unclear how people can inject unregulated, unapproved, and uninspected products.
The FDA's adverse events database shows 10 deaths related to compounded semaglutide over two years, although the causes of death are not specified. These reports serve as a warning system but do not provide definitive scientific evidence.
Novo Nordisk's Efforts:
Novo Nordisk has taken steps to address the shortage and ensure patient safety. Jorgensen hopes that regulatory oversight will change over time, particularly for compounded versions of Wegovy. The company has expanded manufacturing capacity and engaged in ongoing communication with the FDA. While all dose strengths of Ozempic and Wegovy are now listed as available, the drugs remain on the FDA's shortages list.
(Input From Various Sources)
(Rehash/Neha Kamble/MSM)
