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August 1, 2024August 2, 2024 - Semaglutide products are being sold online, with products likely unregistered or unlicensed, according to a research letter published online Aug. 2 in JAMA Network Open.
Amir Reza Ashraf, Pharm.D., from the University of Pécs in Hungary, and colleagues conducted a risk assessment of semaglutide online sourcing. Websites advertising semaglutide without a prescription were cataloged in July 2023; those meeting inclusion criteria were selected for a product test buy protocol. Two 0.25mg dose prefilled pens or equivalent injection vials were ordered from each website and compared to genuine Ozempic brand 1mg semaglutide solution.
Six online vendors classified as not recommended or rogue and offering parenteral semaglutide products were included in the test buys. Three offered prefilled 0.25mg/dose semaglutide injection pens and three sold vials of lyophilized semaglutide. The researchers found that genuine Ozempic scored the full 22 points on the International Pharmaceutical Federation (FIP) checklist, while test purchased products scored 8 or 9; clear discrepancies were seen in regulatory registration information, accurate labeling, and evidence that products were likely unregistered or unlicensed. One sample had elevated endotoxin, indicating possible contamination. The presence of semaglutide was revealed in all samples, with considerably low purity levels (7 to 14 percent versus 99 percent advertised). In each sample, the measured semaglutide content substantially exceeded the labeled amount.
"Semaglutide products are actively being sold without prescription by illegal online pharmacies, with vendors shipping unregistered and falsified products," the authors write. "Two websites evaluated were sent FDA warning letters for unlawful sale of unapproved and misbranded semaglutide."
Read full article from JAMA Network Open HERE.