This content material initially appeared on On a regular basis Well being. Republished with permission.
By Kaitlin Sullivan
Medically Reviewed by Adam Gilden, MD, MSCE courtesy of American School of Life-style Medication
Demand for Ozempic, Wegovy, Zepbound, and Mounjaro has led to the rise of on-line firms promoting what they declare are cheaper variations of the once-a-week injectable medicines. However regulation is murky, and it’s unclear if these alternate options are secure or efficient.
Sufferers face ongoing roadblocks to getting prescriptions and insurance coverage protection. And not using a producer’s coupon or insurance coverage, Wegovy prices $1,350 a month, in response to its producer, Novo Nordisk. Zepbound prices over $1,000, in response to maker Eli Lilly.
Pharmaceutical firms are additionally straining to supply sufficient of those medicines to maintain up with demand, resulting in shortages.
The result’s the expansion of a distinct segment business of so-called compounding pharmacies promoting “home made” variations of those weight reduction medicine: compounded semaglutide (as an alternative choice to Ozempic or Wegovy) and compounded tirzepatide (as a stand-in for Mounjaro and Zepbound).
In early 2024, a warning by the U.S. Meals and Drug Administration (FDA) targeted on the potential risks of compounded semaglutide, with the company citing experiences of unanticipated well being issues in individuals utilizing the medicine.
It’s a danger many individuals seem keen to absorb their quest to drop a few pounds.
When Insurance coverage Gained’t Cowl Wegovy, Desperation Could Set In
Sunnie (full identify withheld for privateness), 50, has all the time had a tough time quieting her thoughts on the subject of meals. “I really feel like I’m hardwired to overeat,” she says.
Weight problems runs in her household. Her mom misplaced 100 kilos twice in her life however gained it again.
Sunnie slowly gained weight whereas bearing and elevating her three kids, reaching a physique mass index of 45. Her physician put her on Contrave, a weight reduction capsule that mixes bupropion (an antidepressant) and naltrexone (a drug used to deal with opioid and alcohol use problems). Contrave prices about $100 per thirty days and is FDA-approved for long-term use in weight administration.
“It helped me management my ideas about meals by suppressing these needs and impulses within the mind,” says Sunnie. “However it stopped working.”
She was able to attempt once more when her physician wrote her a prescription for the semaglutide drug Wegovy. Semaglutide is a GLP-1 receptor agonist, a drugs that mimics a pure hormone referred to as GLP-1 that’s launched within the gastrointestinal tract in response to consuming. GLP-1 prompts the physique to launch insulin, which reduces blood sugar ranges, and interacts with the mind to curb urge for food and sign a sense of fullness.[1]
The FDA permitted Wegovy in 2021 for adults with weight problems or for individuals who are chubby and have at the least one weight-related situation, comparable to hypertension, kind 2 diabetes, or excessive ldl cholesterol.
That’s when Sunnie ran right into a wall: As a result of she doesn’t have a weight-related situation along with weight problems, her insurance coverage wouldn’t cowl Wegovy.
“I felt so defeated. I used to be persevering with to realize weight. I felt like I used to be uncontrolled, and I wanted one thing to get again in management,” she says.
Sunnie works at a hospital, which is the place she heard a few cheaper different to Wegovy: compounded semaglutide, accessible via a nurse who advised Sunnie she was reselling it from a compounding pharmacy. A couple of coworkers have been taking the medicine with success, so Sunnie determined to go for it, shopping for a month’s provide for lower than $300.
“I perceive there’s danger. I do know it may very well be something,” says Sunnie. “I really feel determined. I really feel like gaining weight is greater than me, and I’ve come to the conclusion that I would like medicine to assist me.”
Sunnie began shedding pounds rapidly, and observed a drastic discount in her urge for food, one thing that used to regulate her.
“Once I’m on weight reduction medicine, I can really feel the distinction between my mind telling me I’m hungry and my precise abdomen telling me I’m hungry. I do know I eat out of tension and tedium, and there are a whole lot of psychological causes I eat, however I’m capable of separate these on semaglutide,” she says.
Are Compounded Semaglutide and Tirzepatide Authorized?
About 7,500 licensed pharmacies in america specialise in compounding.[2] These pharmacies combine, alter, or mix FDA-approved medicine with totally different substances for individuals with explicit wants, comparable to people who could also be allergic to a sure dye within the brand-name medicine.
If there’s a scarcity of a drug, compounded variations change into authorized in america. In Could 2023, the FDA included each Ozempic and Wegovy on its drug shortages listing, legalizing compounded variations of the medicine.
The FDA acknowledges that compounded medicine can fill an necessary want, nevertheless it additionally warns that they “pose a better danger to sufferers than FDA-approved medicine as a result of they don’t bear FDA premarket evaluate for security, effectiveness, or high quality.”[3]
Novo Nordisk says it doesn’t promote its patented semaglutide for compounding, elevating questions as to what precisely goes into compounded variations. Nonetheless, the chemical formulation for semaglutide and tirzepatide are publicly accessible.
No generic type of semaglutide exists, although compounded medicine are sometimes marketed as such. The corporate has filed at the least a dozen lawsuits in opposition to medical spas, weight reduction or wellness clinics, and compounding pharmacies promoting questionable compounded or so-called generic variations of semaglutide.[4]
In keeping with the FDA, compounded variations of Ozempic and Wegovy could swap out pure semaglutide for salt-based types, which haven’t been proven to be secure and efficient in medical trials. The FDA has obtained experiences of antagonistic results from individuals who take compounded semaglutide.
Pharmacies promoting compounded semaglutide generally embody nutritional vitamins comparable to B12 within the combine to allegedly increase weight reduction, a declare for which there isn’t any stable proof.[5]
Compounded Semaglutide and Tirzepatide Are Too Dangerous, Consultants Say
Juliana Simonetti, MD, a codirector of the excellent weight administration program on the College of Utah in Salt Lake Metropolis, says that it’s “absolute madness” that insurance coverage firms so typically deny protection for injectable weight reduction medicine to individuals with weight problems, even for sufferers who’ve used these medicines to get prediabetes below management. She understands what’s driving individuals to hunt alternate options.
However, she says, there isn’t any method to know for certain the situations that compounded medicine are created in, including that anybody shopping for compounded medicine from a doubtful supply runs the chance of utilizing medicines that pose security dangers and should not even be sterile.
“I’m very clear in telling my sufferers to not get compounded variations. I really feel their ache and desperation, however I’m telling them to not do it as a result of these are harmful practices,” she says.
Andrew Kraftson, MD, the director of the load navigation program at Michigan Medication in Ann Arbor, believes strongly within the worth of medicines like semaglutide and understands why individuals are scrambling to get the medicine. He factors out that weight problems is extremely stigmatized and undertreated.
“There’s this sense of urgency that’s driving individuals to make rash choices,” he says. “They really feel like, That is on the market now. I ought to have been on it yesterday.”
However with out FDA oversight, Dr. Kraftson says, compounded variations are too dangerous. “It’s problematic that there’s this inherent battle of curiosity,” he says about suppliers who is likely to be keen to compromise security in pursuit of revenue.
Plus, he says, individuals who purchase weight reduction medicines on a budget aren’t usually getting the dietary counseling to be certain that they’re staying wholesome when drastically reducing energy.
“Meals as drugs is a crucial element right here,” Kraftson says. “Anybody might drop a few pounds on 800 energy a day within the type of Twinkies, nevertheless it doesn’t imply they need to.”
Oral Semaglutide and Tirzepatide
Some on-line compounding pharmacies at the moment are promoting semaglutide and tirzepatide within the type of a capsule or liquid. These substances, purportedly utilizing the identical lively substances which might be present in Wegovy and Zepbound, should not swallowed however as an alternative dissolve below the tongue. That is known as sublingual supply.
Are sublingual GLP-1 tablets and liquid suspensions authorized? Compounding pharmacies are allowed to alter the type of prescription medicines for sufferers when a health care provider has indicated that “the commercially accessible medicine isn’t acceptable,” says Tenille Davis, PharmD, the chief advocacy officer on the Alliance for Pharmacy Compounding. For sufferers with a extreme concern of needles or allergic reactions to inactive substances in injectable options, sublingual administration gives an answer. However there has by no means been any revealed research of sublingual GLP-1s, and the security and efficacy of such substances could also be extraordinarily questionable.
Dr. Davis says that at the least one massive compounding pharmacy has carried out in-house research displaying that semaglutide salts may be absorbed within the oral cavity via dissolvable tablets or tinctures positioned below the tongue. However different consultants are skeptical, warning that it’s doubtless that solely small quantities of the lively ingredient are absorbed this fashion.
“I don’t suppose they are going to be efficient,” says Dr. Simonetti. “We will’t take one thing that’s injected after which simply put it below our tongue and have it work the identical method.”
Some Compounded Medication Are Riskier Than Others
Simonetti empathizes with sufferers who’re desperately making an attempt to entry these weight reduction medicines.
“I perceive individuals are determined and the way the choice rolls round to decide on these medicines from a compounded pharmacy,” she says.
If somebody does select to buy compounded semaglutide, Simonetti gives a couple of bits of recommendation to make sure the absolute best security. First, she recommends checking the FDA’s listing of licensed compounding pharmacies.
“It is a good place to start out. You continue to don’t know what you’re getting, however going with an organization on this listing reduces the chance that you just’re injecting your self with micro organism if it’s getting below the pores and skin,” she says.
The Nationwide Affiliation of Boards of Pharmacy additionally has a database that permits individuals to seek for pharmacies by their web site to weed out ones which might be fraudulent.
Discover our suggestions for the greatest on-line GLP-1 packages, together with Henry Meds, Discovered, and Noom Med.
Folks ought to all the time ask the producer for details about what number of milligrams of lively substances are in every dose. Although the exact nature of those substances could also be a thriller, having at the least an thought of how a lot semaglutide-like substance is in every dose may help clinicians assist their sufferers with food plan and drugs administration.
“Loads of compounded medicine are available in items,” Simonetti says. “I don’t know what number of milligrams are within the unit, particularly if they’re mixing it with different substances.”
In case you can speak to your physician earlier than reaching out to a compounding pharmacy, Davis recommends asking about compounding pharmacies they’ve labored with earlier than and belief. She additionally says individuals ought to name the pharmacies and ask about their high quality program and for data on the checks which were carried out on their sterile merchandise. The pharmacy needs to be keen to offer a certificates of purity that claims that the drugs is pure and sterile.
“If the pharmacist is hesitant to debate these sorts of issues, I’d select one other pharmacy,” she says.
Watch out for Unlawful GLP-1 Medication
Whereas compounding pharmacies could appear to be working in a regulatory grey space, different on-line suppliers interact in definitively unlawful practices. A latest survey of the web market recognized greater than 100 web sites claiming to promote semaglutide that may be ordered with no prescription. Pharmacies can’t legally present GLP-1 medicine with no physician’s prescription.
When researchers ordered semaglutide from six of those web sites, three suppliers by no means despatched any product in any respect, and as an alternative demanded extra money: They have been outright scams. The opposite three suppliers did ship some drugs containing semaglutide, however lab checks confirmed that the lively ingredient was included in inaccurate concentrations. One of many samples was contaminated with endotoxin and should have been toxic.[6]
Consultants agree that utilizing medicines from unlawful sources is very harmful, because the efficacy and security of such medicines is totally unknown.
The Takeaway
On-line compounding pharmacies have begun to supply a dizzying number of knockoff GLP-1 medicine, however most consultants are nervous about off-brand Ozempic and comparable merchandise. Whereas the FDA has not assessed the security or efficacy of any compounded medicine, you’ll be able to take steps to scale back the dangers of shopping for weight reduction medicine on-line.
