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 Faculty 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. With out a producer’s coupon or insurance coverage, Wegovy prices $1,350 a month, based on its producer, Novo Nordisk. Zepbound prices over $1,000, based on 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 “selfmade” variations of those weight reduction medication: compounded semaglutide (as an alternative 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) centered on the potential risks of compounded semaglutide, with the company citing experiences of unanticipated well being issues in individuals utilizing the remedy.
It’s a danger many individuals seem keen to soak up their quest to shed weight.
When Insurance coverage Received’t Cowl Wegovy, Desperation Could Set In
Sunnie (full title withheld for privateness), 50, has all the time had a tough time quieting her thoughts in the case 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 tablet that mixes bupropion (an antidepressant) and naltrexone (a drug used to deal with opioid and alcohol use issues). Contrave prices about $100 monthly and is FDA-approved for long-term use in weight administration.
“It helped me management my ideas about meals by suppressing these wishes and impulses within the mind,” says Sunnie. “Nevertheless it stopped working.”
She was able to strive once more when her physician wrote her a prescription for the semaglutide drug Wegovy. Semaglutide is a GLP-1 receptor agonist, a medicine 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 authorised Wegovy in 2021 for adults with weight problems or for individuals who are chubby and have a minimum of one weight-related situation, akin to hypertension, sort 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, out there by a nurse who informed Sunnie she was reselling it from a compounding pharmacy. Just a few coworkers had been taking the remedy 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 might be something,” says Sunnie. “I really feel determined. I really feel like gaining weight is larger than me, and I’ve come to the belief that I would like remedy to assist me.”
Sunnie began shedding pounds shortly, and seen a drastic discount in her urge for food, one thing that used to regulate her.
“After I’m on weight reduction remedy, 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 hysteria and tedium, and there are a number of psychological causes I eat, however I’m in a position to 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 medication with totally different substances for individuals with explicit wants, akin to people who could also be allergic to a sure dye within the brand-name remedy.
If there’s a scarcity of a drug, compounded variations grow to be authorized in america. In Could 2023, the FDA included each Ozempic and Wegovy on its drug shortages listing, legalizing compounded variations of the medication.
The FDA acknowledges that compounded medication can fill an essential want, but it surely additionally warns that they “pose a better danger to sufferers than FDA-approved medication as a result of they don’t endure FDA premarket evaluation 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 out there.
No generic type of semaglutide exists, although compounded medication are sometimes marketed as such. The corporate has filed a minimum of 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 varieties, which haven’t been proven to be secure and efficient in medical trials. The FDA has acquired experiences of antagonistic results from individuals who take compounded semaglutide.
Pharmacies promoting compounded semaglutide generally embody nutritional vitamins akin to B12 within the combine to allegedly enhance weight reduction, a declare for which there isn’t a stable proof.[5]
Compounded Semaglutide and Tirzepatide Are Too Dangerous, Specialists 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 medication to individuals with weight problems, even for sufferers who’ve used these medicines to get prediabetes beneath management. She understands what’s driving individuals to hunt alternate options.
However, she says, there isn’t a option to know for positive the circumstances that compounded medication are created in, including that anybody shopping for compounded medication from a doubtful supply runs the chance of utilizing medicines that pose security dangers and will 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 burden 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 medication. He factors out that weight problems is extremely stigmatized and undertreated.
“There’s this sense of urgency that’s driving individuals to make rash selections,” 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 may be keen to compromise security in pursuit of revenue.
Plus, he says, individuals who purchase weight reduction medicines on a budget aren’t sometimes getting the dietary counseling to make sure that they’re staying wholesome when drastically slicing energy.
“Meals as medication is a vital part right here,” Kraftson says. “Anybody might shed weight on 800 energy a day within the type of Twinkies, but it surely 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 tablet or liquid. These substances, purportedly utilizing the identical energetic substances which are present in Wegovy and Zepbound, usually are not swallowed however as a substitute dissolve beneath the tongue. That is known as sublingual supply.
Are sublingual GLP-1 drugs 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 out there remedy will not be acceptable,” says Tenille Davis, PharmD, the chief advocacy officer on the Alliance for Pharmacy Compounding. For sufferers with a extreme worry of needles or allergy symptoms to inactive substances in injectable options, sublingual administration gives an answer. However there has by no means been any revealed examine of sublingual GLP-1s, and the protection and efficacy of such substances could also be extraordinarily questionable.
Dr. Davis says that a minimum of one massive compounding pharmacy has carried out in-house research exhibiting that semaglutide salts could be absorbed within the oral cavity by dissolvable tablets or tinctures positioned beneath the tongue. However different consultants are skeptical, warning that it’s doubtless that solely small quantities of the energetic ingredient are absorbed this manner.
“I don’t assume they are going to be efficient,” says Dr. Simonetti. “We are able to’t take one thing that’s injected after which simply put it beneath our tongue and have it work the identical manner.”
Some Compounded Medication Are Riskier Than Others
Simonetti empathizes with sufferers who’re desperately attempting 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 just a few bits of recommendation to make sure the very best security. First, she recommends checking the FDA’s listing of licensed compounding pharmacies.
“This can be a good place to begin. You continue to don’t know what you might be 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 beneath 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 are fraudulent.
Discover our suggestions for the greatest on-line GLP-1 packages, together with Henry Meds, Discovered, and Noom Med.
Individuals ought to all the time ask the producer for details about what number of milligrams of energetic substances are in every dose. Although the exact nature of those substances could also be a thriller, having a minimum of an concept of how a lot semaglutide-like substance is in every dose can assist clinicians help their sufferers with eating regimen and medicine administration.
“Loads of compounded medication are available items,” Simonetti says. “I don’t know what number of milligrams are within the unit, particularly if they’re mixing it with different substances.”
When 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 info on the exams which have been carried out on their sterile merchandise. The pharmacy must be keen to supply 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 current survey of the net market recognized greater than 100 web sites claiming to promote semaglutide that may be ordered and not using a prescription. Pharmacies can’t legally present GLP-1 medication and not using a 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 a substitute demanded more cash: They had been outright scams. The opposite three suppliers did ship some medication containing semaglutide, however lab exams confirmed that the energetic ingredient was included in inaccurate concentrations. One of many samples was contaminated with endotoxin and will have been toxic.[6]
Specialists agree that utilizing medicines from unlawful sources is particularly 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 medication, however most consultants are nervous about off-brand Ozempic and comparable merchandise. Whereas the FDA has not assessed the protection or efficacy of any compounded medication, you’ll be able to take steps to scale back the dangers of shopping for weight reduction medication on-line.
Assets We Belief
