麻豆传媒

A qualitative study of semaglutide (Ozempic, Wegovy) purchases over the internet without a prescription uncovered scams, low purity levels, and possible contamination of products.

Quality testing of semaglutide products purchased from "rogue" or otherwise questionable online sellers turned up elevated levels of endotoxin (8.95 EU/mg) suggesting potential contamination in one out of three tested, although no viable microorganisms were detected, reported Tim Mackey, MAS, PhD, of the University of California San Diego, and colleagues.

While the samples contained semaglutide, they all contained higher concentrations than indicated on the label, such that even correct use would result in 29% to 39% more drug per injection than expected, Mackey's group explained in a research letter.

Liquid chromatography-mass spectrometry tests also showed lower purity levels than advertised (7-14% vs 99%).

"These risk factors indicate likely falsification that does not meet legitimate product quality standards," the researchers wrote. "U.S. poison centers have reported a 1,500% increase in calls related to semaglutide, highlighting the need for enhanced pharmacovigilance including for online sourcing harms."

Mackey and colleagues attempted to purchase three additional semaglutide products, but these turned out to be scams and were never received. The vendors requested extra payments to "clear customs," ranging from $650 to $1,200. These scams were confirmed as fraudulent by customs agencies.

The injectable form of the GLP-1 receptor agonist semaglutide has skyrocketed in popularity in recent years following approvals for type 2 diabetes, chronic weight management, and most recently cardiovascular prevention in patients with overweight/obesity and preexisting heart disease. The spike in demand has led to shortages of multiple dose levels, opening the door for compounders.

FDA recently warned about overdoses with compounded semaglutide, both from patient error such as drawing the wrong dose from multi-dose vials, and from physician miscalculation of intended doses with different concentrations.

Semaglutide-maker Novo Nordisk has on compounded semaglutide after one review found high levels of known impurities and the presence of unknown impurities in some compounded semaglutide products. One product tested consisted of more than 24% impurities, including unknown ones.

Mackey and colleagues' analysis started with online searches using Google and Bing looking for websites advertising prescription-free semaglutide in July 2023. This search yielded 1,080 hyperlinks, 29% being for online pharmacies. Of the online pharmacies, 42% belonged to known illegal pharmacy operations.

The researchers settled on six online vendors selling parenteral semaglutide products that were listed as "rogue" by LegitScript or not recommended by the National Association of Boards of Pharmacy. Two of the websites -- and -- have been sent FDA warning letters about the unlawful sale of unapproved semaglutide.

All six sellers had advertisements related to weight loss and obesity on their product pages. Many highlighted the fact that no prescription was required, with one even advertising "without a doctors prescription now!!!" None of the six vendors required an assessment of patients' health prior to purchase.

For the test buys, the researchers bought two 0.25-mg per dose prefilled pens or equivalent semaglutide injection vials from each site. Three sites offered this dose of pens, while the other three vendors sold vials of lyophilized semaglutide to be reconstituted to solution for injection (1-3 mg).

Mackey's group then compared the online products against a genuine Ozempic-brand 1-mg semaglutide solution for injection in a prefilled pen. Using the International Pharmaceutical Federation's checklist for visual inspection, genuine semaglutide scored the full 22 points. Meanwhile, the online products scored 8 or 9 points, "with clear discrepancies in regulatory registration information, accurate labeling, and evidence products were likely unregistered or unlicensed."

The average price was $218.50, ranging from $113 to $360 for the smallest dose and quantity. The researchers pointed out that higher priced online products were excluded from their analysis, thereby limiting the generalizability of the findings. The small number of samples tested was another limitation.

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