By Robin Foster HealthDay Reporter<\/b>
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THURSDAY, Nov. 7, 2024 (HealthDay News) — The head of the company that makes the diabetes and obesity drugs Ozempic and Wegovy has warned that compounded versions of the active ingredient in those medications have now been linked to at least 100 hospitalizations and 10 deaths.<\/p>\n
\u201cHonestly, I\u2019m quite alarmed by what we see in the U.S. now,\u201d Novo Nordisk President and CEO Lars Fruergaard Jorgensen<\/a> told CNN <\/em>on Wednesday. \u201cPatients who believe that they\u2019re getting access to a safe product, and they believe they\u2019re getting semaglutide \u2026 I know for a fact that they are not getting semaglutide, because there\u2019s only one semaglutide, and that\u2019s produced by Novo Nordisk, and we don\u2019t sell that to others.\u201d<\/p>\n Compounded drugs are made by pharmacies or manufacturers other than the companies that make approved versions of those medicines, and they typically are allowed when there is a shortage of those drugs.<\/p>\n Semaglutide, and other GLP-1 drugs like it, have experienced shortages in the past two years as millions of Americans have turned to the medications for help with significant weight loss.<\/p>\n While semaglutide remains on the shortage list, Novo Nordisk noted last week that the last remaining dose in short supply — the lowest dose of Wegovy — is now listed as available, CNN<\/em> reported.<\/p>\n \u201cWe\u2019re collaborating with the FDA, and I think they\u2019re looking into what are some of the considerations they have to make, because I think they\u2019re equally concerned about the health of patients,\u201d Jorgensen said. \u201cSo exactly how that will play out, I think, still remains to be seen.\u201d<\/p>\n Where did the troubling statistics on deaths and hospitalizations surface? They came from the U.S. Food and Drug Administration\u2019s adverse event reporting database<\/a> for semaglutide.<\/p>\n However, the FDA warns<\/a> that reports in that database aren\u2019t yet verified and don\u2019t mean the drugs have actually caused the harms reported. The agency didn\u2019t respond to a request for comment on the reports.<\/p>\n Still, the agency said<\/a> in October that it had received \u201cmultiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors associated with compounded injectable semaglutide products.\u201d<\/p>\n The FDA has also warned that some compounders may be selling salt forms of semaglutide, which contain different active ingredients, and that counterfeit forms of Ozempic are being sold.<\/p>\n Semaglutide<\/a> and a similar GLP-1 drug, tirzepatide<\/a> (Mounjaro\/Zepbound), had been on the FDA\u2019s shortages list since 2022, as the popularity of the medicines, known as GLP-1 receptor agonists, soared.<\/p>\n Last month, the FDA said the shortage of tirzepatide had been resolved<\/a>, but the agency later posted<\/a> it was re-evaluating that decision amid litigation.<\/p>\n Meanwhile, the FDA told CNN<\/em> last week that it\u2019s \u201ccurrently working to determine whether the demand or projected demand for semaglutide within the United States exceeds the available supply.\u201d<\/p>\n More information<\/strong><\/p>\n The FDA has more on the dangers of compounded GLP-1 drugs<\/a>.<\/p>\n