Why buying weight loss medications without a prescription is risky

IIn light of ongoing shortages of the obesity and diabetes drugs known as GLP-1s, patients have turned to a wide variety of sources for the drugs, including medical spas and telehealth sites that offer compounded versions of the drugs prescribe. But a new article published in JAMA network opened highlights one of the riskiest sources of off-brand medicines: illegal online pharmacies that completely circumvent the prescription.

Researchers from the University of San Diego and the University of Pécs in Hungary found that semaglutide ordered from these illegal sites contained significantly more of the drug than stated on the label. One sample also contained signs of possible bacterial contamination during production.

“It’s just a very risky endeavor to buy this product online,” said Tim Mackey, a professor of global health at the University of California, San Diego and co-author of the study. “Just because it is online, accessible and sold without a prescription does not mean it is authentic.”

Concerns are growing about the safety risks of generic versions of popular obesity drugs – both counterfeit and compounded versions. Last week, the Food and Drug Administration published a report be alert to the risks of compounded GLP-1s, citing side effects such as severe vomiting linked to dosing errors – some of which even require hospitalization. In May, Australia banned compounded versions of the drugs due to difficulties in ensuring their safety.

The U.S. Poison Centers reported nearly 5,000 calls about GLP-1 exposure in 2023 – a more than fivefold increase from calls reported in 2019. This year, notifications are on track to reach nearly 8,000. Of these exposure calls, 191 have been explicitly attributed to compound GLP-1s: 159 this year and 32 in 2023.

Prescribing the compounded drugs — which have not been approved by the FDA or evaluated for safety or effectiveness — is currently made possible by existing shortages of Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy, both of which are approved for the treatment of obesity. As long as the brand-name medications are not readily available, compounding pharmacies can legally produce and sell unbranded versions of the medications.

Off-brand medicines are often sold in vials and patients must prepare the correct dose themselves using a syringe, increasing the risk of dosing errors. In contrast, the brand of semaglutide approved for obesity is sold in prefilled pens. According to Kait Brown, clinical director of American Poison Centers, 82% of poison control center calls about GLP-1 exposure were related to medication errors.

Researchers’ analysis of semaglutide from illegal online pharmacies, where users can buy the drugs without a prescription, points to additional risks.

When researchers searched for semaglutide without a prescription in July 2023, they came across 134 illegal online pharmacies. Six of them purchased semaglutide in 0.25 mg pens or vials. Of those six, only three showed up at their door: half of the companies tried to swindle users out of extra money for what was advertised as Ozempic, demanding hundreds of extra dollars to “go through customs” and make delivery. complete.

There were safety concerns with all three vials of semaglutide that did arrive.

All three had much more semaglutide than stated on the label – between 29% and 39% more, increasing the risk of incorrect dosing of the medication. One vial showed signs of non-sterile conditions during production, with elevated levels of endotoxin, a disappearance of bacteria, although further examination found no viable insects in the sample.

“This study demonstrates two very different forms of patient risk,” Mackey said. “One: you’re just being ripped off. That’s not great, but at least you’re not getting insulin, or you’re not getting a product that might have contaminants in it. And secondly, you get something that has too much in it, because the counterfeiters want to make sure you come back for the product.”

Mackey and his co-authors acknowledged that the small number of doses tested limits their analysis. Still, they concluded that “illegal online pharmacies, which operate without valid licenses and sell medications such as semaglutide without a prescription, pose a consumer risk for ineffective and dangerous products.”

Of the three sites where vials were tested, two have received warning letters from the FDA for selling off-brand and unapproved medications since the study was conducted. STAT previously reported on patients using these sites, some of which market themselves as providers of laboratory-grade peptides that sell compounds for research purposes only.

“Despite statements on the labeling of your products marketing your products as ‘research chemicals only’ and ‘not for human consumption’, evidence obtained from your website indicates that your products are intended as drugs for human use,” said the newspaper of February 2011. warning letter for one of the locations.

That site, along with the third pharmacy whose vials were analyzed in the study, were still active as of August 1, offering semaglutide for sale, although both were out of stock. One of the scam pharmacies is still urging users, in 50-point bold letters, to “Buy Ozempic online without a prescription.”

Since the researchers conducted their analysis, online marketing of generic GLP-1s has shifted to compounding pharmacies with their own safety concerns, Mackey said. But “there’s a lot of blurring of the lines, I would say, between compounding pharmacies and finished products, and online pharmacies and suppliers of high-end chemicals,” he said. “And the last group that needs to find out is the consumer.”

Doctors have raised concerns about the risks of counterfeit and compounded GLP-1s as patients continue to seek them in light of shortages and lack of insurance coverage for the expensive brand-name drugs.

Online sellers that don’t require a prescription “should be an immediate red flag to patients that the seller does not have the patient’s best interest in mind,” said Cate Varney, director of obesity medicine at UVA Health, which discourages patients from using the medication. drug not approved by the FDA. But if they are prompted to use prescription compounded medications, she encourages them to get as much information as possible from the pharmacy about where the drug came from, where it was manufactured and that pharmacy’s license number. “If they can’t give you that information up front, or if they’re weird about giving it, I would avoid any company that wouldn’t be transparent about that information,” she said.

The availability of compounded semaglutide may decrease as the supply of branded drugs, including Zepbound and Wegovy, increases. Yesterday, Eli Lilly CEO David Ricks said the Zepbound shortage will likely end this week. Bloomberg News reported.

For emergency assistance, call Poison Help at 1.800.222.1222 to speak with a poison expert, or visit PoisonHelp.org for support and resources.