August 6, 2024 – The unbridled demand for weight reduction drugs has led to an increase in non-traditional versions which can be Compounding pharmacies and can be found online and in cosmetic medical spas and wellness clinics. But the compounded versions put people prone to overdose, the FDA warned, and the situation doesn't seem like improving.
Now, latest research shows many web sites that Weight loss Buying the drug semaglutide online with out a prescription is fraud or selling potentially toxic liquids that don’t contain the stated amount of the drug. The researchers paid between $113 and $360 for a single dose of the products they ordered online. The retail price for a comparable dose (a 0.25-milligram Wegovy pen) is about $325, and the drug is meant to be taken weekly.
Although several of those drugsoften known as GLP-1approved for weight reduction, the FDA warning specifically addressed dosing errors related to compounded semaglutide products meant to be injected. Some of those were so severe that patients ended up within the hospital. In one reported case, a scarcity of clear dosing instructions from a provider – a telemedicine practitioner who prescribed the compounded version – led the patient to hunt advice online. Ultimately, the person took five times the intended dose.
“Patients may receive different concentrations and vial sizes, and they may administer the entire amount, which sometimes amounts to more than a month,” explained Masha Yemets, PharmD, a clinical toxicologist on the Maryland Poison Center on the University of Maryland School of Pharmacy. “So they can make a 10-fold or 20-fold or even greater dosing error,” she said.
An “almost over-the-counter” drug on a prescription market
The manufacture of compounded drugs just isn’t illegal; the method is permissible, particularly during drug shortages, so long as it meets certain quality control and other requirements of the Federal Food, Drug and Cosmetic Act.
Currently, Novo Nordisk is the one company within the U.S. that holds patents for semaglutide, and there aren’t any FDA-approved generics. This signifies that semaglutide purchased from a pharmacy, cosmetic medical spa, or online just isn’t the unique, has not been thoroughly tested or meets quality standards, and will be downright dangerous.
“The problem is that when drugs are manufactured (legally and safely), the active pharmaceutical ingredient, or API, comes from an FDA-approved generic manufacturer. Here we have an API that is not a generic and is not necessarily manufactured the way Novo makes it. So we don't know what the starting product is,” said Dr. Angela Fitch, chief medical officer of healthcare company Knownwell and former president of the Obesity Medicine Association.
“We have turned the treatment of a serious chronic disease – obesity – into an almost over-the-counter commercial market. But safety is not regulated or monitored,” she said.
Dosing errors are the important problem
Approved semaglutide injections for weight reduction are dosed in milligrams, have standard concentrations and are currently available only in prefilled pens. In its warning, the FDA said many patients haven’t any experience with self-injection and have no idea much about withdrawing the drug from a vial.
Most reports describe patients inadvertently withdrawing greater than the prescribed dose from multi-dose vials—in some cases greater than 20 times the intended dose—and that patients were often unclear about easy methods to measure the intended dose using a syringe.
“Sometimes patients report the dose in units, sometimes in milligrams, sometimes in milliliters,” said Joseph Lambson, PharmD, director of the New Mexico Poison & Drug Information Center on the University of New Mexico Health in Albuquerque. “Often it's a similar story if they've been given double or 10 times the dose. That's one of the easiest mistakes to make.”
Ironically, the FDA also noted that the reports it received described how medical personnel themselves had miscalculated the intended dose when converting milligrams to units or milliliters, further underscoring how easily errors can occur.
But other than mismeasured doses, Fitch said, “we've actually seen patients taking more medication on their own and increasing the dose more quickly because they wanted to get results faster. What they need to understand is to increase the dose gradually. This is not a drug where you can just take the highest dose and it's OK; you need to increase it slowly over time.”
The uncomfortable side effects reported mainly affect the digestive system, but some have been significant. Yemets noted that patients are sometimes dropped at the emergency room with repeated vomiting and diarrhea so severe that they need treatment to replenish their fluids and stop the vomiting.
But that’s just the tip of the iceberg.
“There are more serious side effects associated with these drugs overall, things like acute pancreatitis, whether it's brand-name drugs, commercially available drugs or compounded semaglutide,” she said.
Other uncomfortable side effects reported by the FDA include abdominal pain, fainting, headache, migraine, and gallstones.
The big picture
Between 2019 and June 30, 2024, calls to poison control centers increased by greater than 1,500%, reporting a complete of three,866 cases of exposure to GLP-1 drugs. This yr alone, America's Poison Centers – a nonprofit network that gives medical advice on poisonings across the U.S. – has reported 159 cases of exposure, said Kait Brown, PharmD, clinical executive director. Overall, between Jan. 1, 2023, and June 30, 2024, “82% of those contacts were due to a medication error,” she said.
However, Brown stressed that these data apply to all GLP-1 drugs and should not limited to semaglutide or unapproved formulations, and that some patients have problems with the official FDA-approved versions of the drugs.
“Ever since these products came on the market, ever since they started being used in patients, there have been dosing errors,” Yemets said. “As recently as late last year, there were many cases with the compounded version that coincided with the FDA putting these drugs on the deficiency list.”
Bridget Pilloud, a author from Washington and Arizona states, said she has already had problems with the approved brand-name drugs.
“The first week I was in the doctor's office and she showed me how to use the pen and it seemed pretty straightforward,” she said. “I was confused by the markings and didn't know that I was supposed to hear the pen click when you turn the wheel.”
Despite watching a YouTube video and re-reading the instructions, Pilloud eventually called her doctor, who again told her it was unclear how much medication she had (or hadn't) received. “The information is counterintuitive,” Pilloud said.
Leigh Fazzina, a pharmaceutical marketing manager within the Philadelphia area, also said that although she visited a good academic clinic and received a prescription for the FDA-approved drug, she was never shown the actual pens or told easy methods to use them. A YouTube tutorial and a call to the drug manufacturer's toll-free number helped her overcome the lack of awareness and use the pen properly, but she believes that without her background, she wouldn't have even known what to do or where to seek out information.
“I must have spent more than an hour searching the Internet. Someone with a health literacy problem would have even more difficulty with this,” she said.
“We definitely get calls about the compounded products,” says Lambson of the New Mexico Poison & Drug Information Center. He says he's helping with a study to find out the share of calls related to compounded drugs, in comparison with others, to get a way of the differences in uncomfortable side effects.
“Stories vary. For example, we don't usually get a tenfold overdose with the manufactured product, but often it is administered with the wrong pen, so patients get double or quadruple the dose,” he said.
How to remain protected
It's vital to know easy methods to dose these medications in keeping with the directions. “Make sure you get these medications from a doctor or pharmacy and that you get counseling on how to take the medication and what side effects to expect,” Lambson advised. The pharmacist may have the option to assist patients using a compounded version learn vital steps, reminiscent of how far to drag back on the syringe or, within the case of the pens, which tabs to drag, which buttons to press and the way long to press them, he said.
If you experience uncomfortable side effects related to the usage of semaglutide or some other GLP-1 inhibitor, stop taking it immediately and call the poison control line at 800-222-1222 to talk with a poison expert or visit PoisonHelp.org for support and resources.
The FDA also encourages patients to report uncomfortable side effects and medicine errors related to these products to their MedWatch adverse event reporting program.