Semaglutide products sold online without a prescription by illegal pharmacies pose multiple risks to users, according to new research published in JAMA Network Open.

Of 6 test purchases of semaglutide products offered online without a prescription, only 3 were received and the other 3 vendors engaged in nondelivery scams where they demanded additional payments ranging from US $650 to $1200 “to purportedly clear customs, confirmed as fraudulent by customs agencies,” researchers reported.

Of the 3 semaglutide products delivered, quality testing revealed 1 had elevated presence of endotoxin (8.95 EU/mg), indicating possible contamination, although investigators did not detect any viable microorganisms. All 3 samples received did contain semaglutide, although with significantly lower purity levels compared to what was advertised (7%-14% vs 99%). Also, in all 3 samples delivered, the semaglutide content (as evaluated by liquid chromatography–mass spectrometry), substantially exceeded the labeled amount by 29% to 39%.

“This qualitative study found that semaglutide products are actively being sold without prescription by illegal online pharmacies, with vendors shipping unregistered and falsified products,” first author Amir Reza Ashraf, PharmD, of the University of Pécs, Pécs, Hungary, and colleagues wrote.

Semaglutide has recently surged in popularity due to widespread media coverage, social media exposure, and celebrity endorsements. Despite semaglutide branded as Wegovy (Novo Nordisk) being approved in 2021 by the US Food and Drug Administration for chronic weight management in persons with obesity or overweight, semaglutide branded as Ozempic (Novo Nordisk—which is only indicated to improve glycemic control in adults with type 2 diabetes—is often used off-label for weight management due to high patient demand, high cost for the branded drug, and drug shortages. Global regulatory agencies, including the FDA and World Health Organization, have issued warnings about the use of counterfeit semaglutide products, however, individuals are still willing and able to find semaglutide products online.

“Illegal online pharmacies, which operate without valid licenses and sell medicines like semaglutide without prescription, represent a consumer risk for ineffective and dangerous products,” Ashraf and colleagues stated.

To examine the risks of obtaining semaglutide products online, researchers searched for websites advertising semaglutide availability without a prescription and ordered products from 6 online vendors that met inclusion criteria. Investigators purchased two, 0.25 mg per dose prefilled pens or equivalent semaglutide injection vials from each vendor. Upon receiving the products, they used the International Pharmaceutical Federation’s (FIP) checklist for visual inspection and to determine potential counterfeit or falsification as compared with genuine Ozempic brand 1 mg semaglutide for injection in a prefilled pen.

The semaglutide products were also tested for quality, including sterility and microbiological contamination. Test purchases and testing were performed between August 2023 and March 2024, according to the study.

Findings

The online search generated 1080 hyperlinks, with 317 links being for online pharmacies and 763 for websites not offering semaglutide for sale, including 615 news and informational websites and 148 telemedicine websites requiring consultation to obtain prescription before buying. Among the 317 links for online pharmacies, 42.27% (n=134) was an illegal pharmacy operation.

Of the 6 vendors classified as “not recommended” or “rogue” by LegitScript and/or National Association of Boards of Pharmacy and included in the test buys, 3 sold prefilled 0.25 mg/dose semaglutide injection pens and 3 offered lyophilized semaglutide to be reconstituted to solution for injection (1-3 mg). All vendors referred to weight loss and obesity on their product page, and the prices for the smallest dose and quantity ranged from $113 to $360 (mean, $218.50).

Investigators observed that while genuine Ozempic scored the full 22 points on the FIP checklist, the 3 test products received scored 8 or 9 with “clear discrepancies in regulatory registration information, accurate labeling, and evidence products were likely unregistered or unlicensed,” they wrote.

Researchers also noted that 2 of the websites included in the analysis were sent FDA warning letters for the unlawful sale of unapproved and misbranded semaglutide.

“Study limitations include limited sample of products tested due to nondelivery scams,” Ashraf et al concluded. “Furthermore, although tested products represent some accessible semaglutide products sold online, higher priced offerings were excluded, limiting generalizability of the findings.”

Reference: Ashraf AR, Mackey TK, Schmidt J, et al. Safety and risk assessment of no-prescription online semaglutide purchases. JAMA Netw Open. Published online August 1, 2024. doi:10.1001/jamanetworkopen.2024.28280