IDue to the ongoing shortage of obesity and diabetes medications known as GLP-1s, patients have turned to multiple sources of medication, including medical centers and telehealth sites that offer a wide range of medications. of drugs. But a new paper published in JAMA Network Open highlights one of the most dangerous sources of over-the-counter drugs: illegal pharmacies that do not have a doctor’s approval.
Researchers from the University of San Diego and the University of Pécs in Hungary found that semaglutide ordered from these illegal sites contained more of the drug than was prescribed. One sample also had signs of bacterial contamination during production.
“It’s a very risky business, going online and buying this product,” said Tim Mackey, a professor of global health at the University of California, San Diego and a co-author of the study. “Just because it’s available online, and can be sold without a prescription, doesn’t mean it’s real.
Concerns about the safety risks of off-brand versions of popular obesity medications are growing – synthetic drugs and compounded versions. Last week, the Food and Drug Administration issued a warning about the dangers of combining GLP-1s, citing adverse events such as severe vomiting associated with dosing errors — some even need to be hospitalized. In May, Australia banned compounded forms of the drug due to safety concerns.
America’s Poison Centers reported about 5,000 calls about GLP-1 exposure in 2023 – a more than fivefold increase from the calls reported in 2019. This year, the calls are on track to reach about 8,000. Of those calls about exposure, 191 were clearly issued from GLP-1s: 159 this year, and 32 in 2023.
The prescription of compounded drugs — not approved by the FDA or evaluated for safety or effectiveness — is now allowed by the existing shortage of Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy, both of which are approved for treating obesity. As long as these types of drugs are not readily available, compounding pharmacies can legally make and sell non-brand name drugs.
Over-the-counter drugs are often sold in vials, and patients must collect the correct dose themselves using a syringe, increasing the risk of dosing errors. Branded semaglutide approved for obesity, on the other hand, is sold in pre-filled pens. Of the calls to the poison control center about exposure to compounded GLP-1, 82% were related to medication errors, according to Kait Brown, chief clinical officer of the American Poison Center.
Researcher’s review of semaglutide from illegal online pharmacies that allow users to buy the drug without a prescription point to other risks.
When researchers searched for over-the-counter semaglutide in July 2023, they turned up 134 illegal online prescriptions. They purchased semaglutide in 0.25-mg pens or injection vials in six of them. Of those six, only three made it to their door: Half of the companies tried to trick users into paying more for what was advertised as Ozempic, demanding hundreds of dollars in “cancel customs” and provide complete goods.
There were safety issues with all three bottles of semaglutide that arrived.
All three had more semaglutide than prescribed – between 29% and 39% more, increasing the risk of abusing the medication. Another vial showed signs of unsanitary conditions during production, with high levels of endotoxin, a reduction from bacteria, although further tests found no active pathogens in the sample.
“This study shows two very different types of patient risk,” Mackey said. One, you are just being scammed. That’s not good, but at least you’re not getting insulin, or you’re not getting a product that might have impurities in it. Second, you get something that has a lot more to it because the scammers want to make sure you come back for the product. ”
Mackey and his co-authors accepted the small number of values tested which limited their analysis. However, they concluded that, “illegal online pharmacies, operating without licenses and selling drugs such as semaglutide without a prescription, represent a danger to consumers for ineffective and dangerous products.”
“Drugs approved by the FDA should only be obtained with a valid prescription from a licensed pharmacy and used under a physician’s supervision or direction,” FDA spokeswoman Amanda Hils wrote. email to STAT. “Buying drugs from unregulated, non-prescription sources without a prescription is dangerous and some websites may appear to be legitimate pharmacies, but they actually work illegally and sell drugs that can be dangerous, even deadly.”
Of the three places where pot was tested, two have received warning letters from the FDA for selling illegal and unlicensed drugs since the study was conducted. STAT has previously reported on patients using these sites, some of which advertise themselves as lab-based peptide vendors selling compounds for research purposes only.
“Despite claims that your product markets your products as ‘research chemicals only’ and ‘not for human use,’ evidence found on your website indicates that the products yours are intended for human use,” read the February warning letter to the person. of places.
That site, along with a third pharmacy whose containers were examined in the study, were still in existence and listed semaglutide for sale as of August 1, although both had expired. . One of the drug scams is asking users, in bold, 50-point font, to “buy Ozempic online without a prescription.”
Since the researchers conducted their analysis, online marketing of over-the-counter GLP-1s has shifted to compounding pharmacies with their safety information, Mackey said. But “there are a lot of blurred lines, I would say, between compounding pharmacies and finished products and online pharmacies and research chemical providers,” he said. . “And the last group that needs to try to find out is the customer.”
Doctors have expressed concern about the dangers of synthetic GLP-1 and GLP-1 compounds as patients continue to seek them out when faced with shortages and lack of insurance for expensive drugs.
Online sellers that don’t require a prescription “should be a red flag to patients that the seller doesn’t have the patient’s best interest at heart,” said Cate Varney, director of obesity medicine at UVA Health, which advocates for patients. to use any. drugs not approved by the FDA. But if they are motivated to use prescription compounded drugs, he encourages them to get as much information as possible from the pharmacy about where the drug came from, where it was made, and the pharmacy’s license number. “If they can’t give you that information up front, or they’re weird about giving it, I would avoid any company that won’t be transparent about that information,” he said.
The availability of combined semaglutide may decrease as the supply of known drugs including Zepbound and Wegovy increases. Yesterday, Eli Lilly CEO David Ricks said that the Zepbound shortage could end this week, Bloomberg News reported.
For emergency help, please call Poison Help at 1.800.222.1222 to speak with a poison specialist, or visit PoisonHelp.org for support and resources.
This story has been updated with FDA input.
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