In the face of ongoing shortages of the weight problems and diabetes drugs referred to as GLP-1s, sufferers have resorted to a big selection of sources for the medicine, together with medical spas and telehealth websites that prescribe compounded variations of the medicine. However a brand new paper revealed in JAMA Network Open highlights one of many riskiest sources of non-branded medicine: unlawful on-line pharmacies that bypass prescription solely.
Researchers from the College of San Diego and the College of Pécs in Hungary discovered that semaglutide ordered from these unlawful websites contained considerably extra of the drug than labeled. One pattern additionally contained indicators of potential bacterial contamination throughout manufacturing.
“It’s only a very, very dangerous enterprise, going surfing and shopping for this product,” stated Tim Mackey, a professor of worldwide well being on the College of California, San Diego and co-author of the examine. “Simply because it’s on-line and it’s accessible and it may be bought and not using a prescription, doesn’t imply it’s genuine.”
Concern over the protection dangers of non-branded variations of fashionable weight problems drugs is on the rise — each counterfeit medicine and compounded variations. Final week, the Meals and Drug Administration issued an alert about the risks of compounded GLP-1s, citing adversarial occasions like extreme vomiting associated to dosing errors — some even requiring hospitalization. In Might, Australia banned compounded variations of the medicine due to the challenges in guaranteeing their security.
America’s Poison Facilities reported almost 5,000 calls about GLP-1 exposures in 2023 — a greater than fivefold improve from calls reported in 2019. This yr, calls are on monitor to succeed in almost 8,000. Of these calls about exposures, 191 have been explicitly attributed to compounded GLP-1s: 159 this yr, and 32 in 2023.
Prescription of the compounded medicine — which aren’t accepted by the FDA or evaluated for security or effectiveness — is presently enabled by the present shortages of Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy, each of which have been accepted for treating weight problems. So long as the branded drugs usually are not available, compounding pharmacies can legally manufacture and promote non-branded variations of the medicine.
Non-branded medicine are sometimes bought in vials, and sufferers should assemble the proper dose themselves utilizing a syringe, growing the chance of dosing errors. Branded semaglutide accepted for weight problems, against this, is bought in pre-filled pens. Of poison management middle calls about compounded GLP-1 publicity, 82% have been associated to medicine errors, in response to Kait Brown, medical managing director of the America’s Poison Facilities.
Researchers’ evaluation of semaglutide from unlawful on-line pharmacies that permit customers to purchase the medicine and not using a prescription level to extra dangers.
When researchers looked for no-prescription semaglutide in July 2023, they turned up 134 unlawful on-line pharmacies. They purchased semaglutide in 0.25-mg pens or injection vials from six of them. Of these six, solely three arrived at their doorstep: Half of the businesses tried to rip-off customers out of additional cash for what was marketed as Ozempic, demanding a whole bunch of additional {dollars} to “clear customs” and full supply.
There have been security issues with all three semaglutide vials that did arrive.
All three had way more semaglutide than labeled — between 29% and 39% extra, including to the chance of misdosing the medicine. One vial confirmed indicators of unsterile circumstances throughout manufacturing, with elevated ranges of endotoxin, a castoff from micro organism, although additional testing discovered no viable bugs within the pattern.
“This examine reveals two very completely different types of affected person threat,” stated Mackey. “One, you simply get scammed. Which isn’t nice, however at the least you don’t get insulin, otherwise you don’t get a product that would have some contaminants in it. And two, you get one thing that has an excessive amount of in it as a result of the counterfeiters wish to just be sure you come again for product.”
Mackey and his co-authors acknowledged the small variety of doses examined limits their evaluation. Nonetheless, they concluded, “unlawful on-line pharmacies, which function with out legitimate licenses and promote medicines like semaglutide with out prescription, characterize a shopper threat for ineffective and harmful merchandise.”
“FDA-approved pharmaceuticals ought to solely be obtained with a sound prescription from a reputable pharmacy and used beneath a prescriber’s supervision or based mostly on their route,” FDA spokesperson Amanda Hils wrote in an e mail to STAT. “Buying pharmaceuticals from unregulated, unlicensed sources and not using a prescription is dangerous and a few web sites could look like reputable on-line pharmacies, however they’re really working illegally and promoting medicines that may be harmful, even lethal.”
Of the three websites from which vials have been examined, two have acquired warning letters from the FDA for promoting misbranded and unapproved medicine for the reason that examine was performed. STAT beforehand reported on sufferers utilizing these websites, a few of which market themselves as laboratory-grade peptide suppliers that promote compounds for analysis functions solely.
“Regardless of statements in your product labeling advertising and marketing your merchandise as ‘analysis chemical substances solely’ and ‘not for human consumption,’ proof obtained out of your web site establishes that your merchandise are meant to be medicine for human use,” reads the February warning letter for one of many websites.
That web site, together with the third pharmacy whose vials have been analyzed within the examine, have been nonetheless up and itemizing semaglutide on the market as of August 1, although they have been each out of inventory. One of many rip-off pharmacies nonetheless invokes customers, in daring, 50-point font, to “purchase Ozempic on-line with out prescription.”
Because the researchers performed their evaluation, the web advertising and marketing of non-branded GLP-1s has shifted towards compounding pharmacies with their very own set of security issues, stated Mackey. However “there’s numerous blurring of the traces, I’d say, between compounded pharmacies and completed product and on-line pharmacies and analysis grade chemical suppliers,” he stated. “And the final group that should attempt to determine that out is the patron.”
Physicians have voiced concern over the dangers of counterfeit and compounded GLP-1s as sufferers proceed to hunt them out within the face of shortages and lack of insurance coverage protection for the costly branded drugs.
On-line sellers who don’t require a prescription “must be an instantaneous crimson flag to sufferers that the vendor doesn’t have the affected person’s greatest curiosity in thoughts,” stated Cate Varney, director of weight problems medication at UVA Well being, who discourages sufferers from utilizing any drug not accepted by the FDA. But when they’re pushed to make use of prescribed compounded drugs, she encourages them to get as a lot data as doable from the pharmacy about the place the medicine got here from, the place it was manufactured, and the license variety of that pharmacy. “If they can’t provide you with that data up entrance, or they’re bizarre about giving that, I’d keep away from any firm that may not be clear about that data,” she stated.
The provision of compounded semaglutide could diminish as provide will increase of branded medicine together with Zepbound and Wegovy. Yesterday, Eli Lilly CEO David Ricks stated that the Zepbound scarcity will probably come to an finish this week, Bloomberg News reported.
For emergency help, please name Poison Assist at 1.800.222.1222 to talk with a poison skilled, or go to PoisonHelp.org for assist and sources.
This story has been up to date with FDA remark.
