MDLinxOff-brand Ozempic Leaves 10 Dead, 100 Hospitalized

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Novo Nordisk’s CEO has reported 100 hospitalizations and 10 deaths linked to compounded versions of semaglutide, raising significant safety concerns. The FDA has documented multiple adverse events related to these unauthorized versions, with dosing errors emerging as a primary risk factor. Only Novo Nordisk produces FDA-approved semaglutide, though compounded versions have proliferated during the current shortage.

Key Points:

• The FDA has recorded 346 adverse events related to compounded semaglutide as of August 31, 2024
• Current semaglutide shortage (as of October 2, 2024) has led to increased use of compounded versions
• Dosing errors stem from both patient self-administration and healthcare professional miscalculations
• Compounded drugs lack FDA approval for safety, effectiveness, and quality standards
• State-licensed pharmacies not classified as outsourcing facilities aren’t required to report adverse events, suggesting actual incident numbers may be higher

“Is it possible that it’s safe? Yes. Do you want to take that chance? I don’t … It’s important to explain to patients that they have to have a little bit of patience on this.”
– Dan Azagury, MD, FACS

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