In the face of ongoing shortages of the weight problems and diabetes drugs generally known as GLP-1s, sufferers have resorted to a wide selection of sources for the medication, together with medical spas and telehealth websites that prescribe compounded variations of the medication. However a brand new paper printed in JAMA Community Open highlights one of many riskiest sources of non-branded medication: unlawful on-line pharmacies that bypass prescription fully.
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, logging on and shopping for this product,” stated Tim Mackey, a professor of world 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 security dangers of non-branded variations of common weight problems drugs is on the rise — each counterfeit medication and compounded variations. Final week, the Meals and Drug Administration issued an alert concerning the dangers of compounded GLP-1s, citing antagonistic occasions like extreme vomiting associated to dosing errors — some even requiring hospitalization. In Might, Australia banned compounded variations of the medication due to the challenges in making certain 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 12 months, calls are on observe to succeed in almost 8,000. Of these calls about exposures, 191 have been explicitly attributed to compounded GLP-1s: 159 this 12 months, and 32 in 2023.
Prescription of the compounded medication — which aren’t permitted by the FDA or evaluated for security or effectiveness — is presently enabled by the prevailing shortages of Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy, each of which have been permitted 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 medication.
Non-branded medication are sometimes bought in vials, and sufferers should assemble the proper dose themselves utilizing a syringe, growing the danger of dosing errors. Branded semaglutide permitted for weight problems, in contrast, is bought in pre-filled pens. Of poison management middle calls about compounded GLP-1 publicity, 82% have been associated to remedy errors, based on Kait Brown, scientific managing director of the America’s Poison Facilities.
Researchers’ evaluation of semaglutide from unlawful on-line pharmacies that permit customers to purchase the medication and not using a prescription level to further 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 lot 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 much more semaglutide than labeled — between 29% and 39% extra, including to the danger of misdosing the remedy. One vial confirmed indicators of unsterile situations throughout manufacturing, with elevated ranges of endotoxin, a castoff from micro organism, although additional testing discovered no viable bugs within the pattern.
“This examine exhibits two very completely different types of affected person danger,” 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 need to just remember to 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 client danger for ineffective and harmful merchandise.”
“FDA-approved pharmaceuticals ought to solely be obtained with a legitimate prescription from a respectable pharmacy and used beneath a prescriber’s supervision or primarily based 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 respectable on-line pharmacies, however they’re truly 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 medication 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 supposed to be medication 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.”
For the reason that 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 concerns, stated Mackey. However “there’s plenty of blurring of the strains, 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 a direct pink flag to sufferers that the vendor doesn’t have the affected person’s greatest curiosity in thoughts,” stated Cate Varney, director of weight problems drugs at UVA Well being, who discourages sufferers from utilizing any drug not permitted by the FDA. But when they’re pushed to make use of prescribed compounded drugs, she encourages them to get as a lot info as doable from the pharmacy about the place the remedy got here from, the place it was manufactured, and the license variety of that pharmacy. “If they can not provide you with that info up entrance, or they’re bizarre about giving that, I’d keep away from any firm that will not be clear about that info,” she stated.
The provision of compounded semaglutide could diminish as provide will increase of branded medication together with Zepbound and Wegovy. Yesterday, Eli Lilly CEO David Ricks stated that the Zepbound scarcity will possible come to an finish this week, Bloomberg Information reported.
For emergency help, please name Poison Assist at 1.800.222.1222 to talk with a poison professional, or go to PoisonHelp.org for assist and assets.
This story has been up to date with FDA remark.
