JMIR Publications

ABSTRACT

Background:

Over the past four decades, obesity has escalated into a global epidemic, with its worldwide prevalence nearly tripling. Pharmacological treatments have evolved significantly, with the recent development of glucagon like peptide‑1 (GLP‑1) agonists, such as semaglutide. However, the off-label use of drugs like Ozempic and Wegovy for cosmetic weight loss has surged in popularity, raising concerns about potential misuse, access limitations for diabetic patients, and the emergence of substandard and falsified products in the unregulated supply chain.

Objective:

This study aimed to conduct a multifactor investigation of product quality and patient safety risks associated with the unregulated online sale of semaglutide by examining product availability, vendor characteristics, and assessing product quality through test purchases.

Methods:

We employed a complex risk and quality assessment methodology combining online market surveillance, search engine result page (SERP) scraping, manual vendor website content assessment, domain traffic analytics, conducting targeted product test purchases, documentation of logistics, visual quality inspection of product packaging, microbiological sterility and endotoxin contamination evaluation according to European and United States Pharmacopeia guidelines, and quantitative sample analysis using liquid chromatography coupled with mass spectrometry (LC‑MS).

Results:

We collected and evaluated 1080 links from SERPs, and identified 317 links belonging to online pharmacies, of which 183 (57.73%) led to legal pharmacies and 134 (42.27%) directed users to 59 unique illegal online pharmacy websites. Web traffic data analysis for the period between July and September 2023 revealed that the top 30 domains directly or indirectly affiliated with illegal online pharmacies accumulated over 4.7 million visits. Test purchases were completed from six illegal online pharmacies with the highest number of links offering semaglutide products for sale without prescription at the lowest price range. Three injection vial purchases were delivered; none of the three Ozempic pre-filled injection pens were received due to non-delivery e‑commerce scams. All purchased vials were considered probable substandard and falsified products, as visual inspection indicated non-compliance in more than half (59-63%) of the evaluated criteria. The semaglutide content of samples substantially exceeded labeled amounts by 28.56-38.69%, although no peptide-like impurities were identified. The lyophilized peptide samples were devoid of viable microorganisms at the time of testing; however, endotoxin was detected in all samples with levels ranging between 2.1645-8.9511 EU/mg. Further, the measured semaglutide purity was significantly low, ranging between 7.70-14.37% and deviating from the 99% claimed on product labels by manufacturers.

Conclusions:

GLP‑1 agonist drugs used for weight-loss, similarly to erectile dysfunction medications more than two decades ago, are becoming the new blockbuster lifestyle medications for the illegal online pharmacy market. Protecting the pharmaceutical supply chain from substandard and falsified weight loss products and raising awareness regarding online medication safety must be a public health priority for regulators and technology platforms alike.