Citing reports of 10 fatalities and more than 100 hospitalizations associated with the uncontrolled forms of the medication used to treat diabetes and obesity, Novo Nordisk CEO Lars Fruergaard Jorgensen issues a warning against compounded semaglutide.
The active component of the well-known diabetic and obesity medications Ozempic and Wegovy, semaglutide, is compounded, and Novo Nordisk CEO Lars Fruergaard Jorgensen has warned of the risks.
Jorgensen claims that these uncontrolled versions have been linked to over 100 hospitalizations and at least 10 patient deaths in the United States, posing serious safety issues.
They feel the medication is safe and effective for them. But that’s not true,” Jorgensen said, pointing out that only Novo Nordisk is the FDA-approved manufacturer of the real drug.
Because it is not held to the same level of regulation and approval as FDA-approved medications, compounded semaglutide-which often gets used during shortages-may be lethal.
While adverse event reports from the FDA’s database raise these concerns, the agency indicates that such reports are not verified and do not prove a cause-and-effect relationship between the drug and the adverse effects.
The compounded formulations of the medication can have unexpected reactions because the compounded version is different from the version that has been approved, and sometimes because the salt forms of semaglutide are altered or modified.
Novo Nordisk is now collaborating with the FDA to put a stop to such things because semaglutide is in high demand. “Clearly, as a company, we’re trying to keep patients safe,” Jorgensen said.
“We would hope that increased access to FDA-approved products would alleviate some of this need for compounded substitutes.”.
