London, Nov 7 Danish pharma giant Novo Nordisk has said it is aware of at least 10 deaths and 100 hospitalisations linked to compounded versions of semaglutide -- the active ingredient in popular diabetes and obesity drugs Ozempic and Wegovy.
The company’s chief financial officer Karsten Munk Knudsen said that the deaths and hospitalisations, recorded in the last two years, were reported in the US Food and Drug Administration’s (FDA) adverse event reporting database for semaglutide.
While the reports are submitted by doctors, patients, drugmakers, and others, they often lack key details. These also do not establish the cause of death.
According to the US FDA, a drug may be compounded for a patient in cases where a patient with an allergy to a certain dye needs a separate medication, or people who cannot swallow a tablet or capsule.
Such drugs are also made by copying the brand-name medicines that are in short supply. The drugs are typically made by combining, mixing, or altering the ingredients to meet demand.
However, these drugs are not FDA-approved.
Amid strict regulations in the US, it was puzzling that people in the country “could inject themselves with a product that was not regulated, approved or inspected,” CEO Lars Fruergaard Jorgensen, told the media.
Besides semaglutide, the company had been looking at other compounded products and identified multiple safety concerns as well as the reports of hospitalisations and deaths, Knudsen also told the media briefing.
This was reported to the FDA by the company. In October, it also 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.
Meanwhile, Novo Nordisk shares jumped 8 per cent after Wegovy sales beat expectations. Sales of Wegovy were 79 per cent higher in the third quarter of 2024 compared to the same period last year, the company said.
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