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 drugs. However regulation is murky, and it’s unclear if these 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, 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 drugs 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) centered on the potential risks of compounded semaglutide, with the company citing reviews of unanticipated well being issues in folks utilizing the remedy.
It’s a danger many individuals seem keen to soak up their quest to shed extra pounds.
When Insurance coverage Received’t Cowl Wegovy, Desperation Could Set In
Sunnie (full title withheld for privateness), 50, has at all times had a tough time quieting her thoughts in terms 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 problems). 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. “But it surely 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 accepted Wegovy in 2021 for adults with weight problems or for many who are chubby and have at the least one weight-related situation, equivalent 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 achieve 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 couple of cheaper various to Wegovy: compounded semaglutide, obtainable by a nurse who informed Sunnie she was reselling it from a compounding pharmacy. A couple of 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 conclusion that I want remedy to assist me.”
Sunnie began losing a few pounds rapidly, and seen a drastic discount in her urge for food, one thing that used to regulate her.
“Once 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 tension and tedium, and there are loads 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 concentrate on compounding.[2] These pharmacies combine, alter, or mix FDA-approved medicine with totally different elements for folks with specific wants, equivalent 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 turn into authorized in america. In Could 2023, the FDA included each Ozempic and Wegovy on its drug shortages checklist, legalizing compounded variations of the medicine.
The FDA acknowledges that compounded medicine can fill an vital want, but it surely additionally warns that they “pose the next danger to sufferers than FDA-approved medicine as a result of they don’t endure FDA premarket assessment 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 obtainable.
No generic type of semaglutide exists, although compounded medicine are sometimes marketed as such. The corporate has filed at the least a dozen lawsuits towards medical spas, weight reduction or wellness clinics, and compounding pharmacies promoting questionable compounded or so-called generic variations of semaglutide.[4]
In accordance 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 scientific trials. The FDA has obtained reviews of hostile results from individuals who take compounded semaglutide.
Pharmacies promoting compounded semaglutide typically embody nutritional vitamins equivalent to B12 within the combine to allegedly increase weight reduction, a declare for which there isn’t a stable proof.[5]
Compounded Semaglutide and Tirzepatide Are Too Dangerous, Consultants Say
Juliana Simonetti, MD, a codirector of the great 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 folks with weight problems, even for sufferers who’ve used these drugs to get prediabetes beneath management. She understands what’s driving folks to hunt options.
However, she says, there isn’t a strategy to know for positive the situations that compounded medicine are created in, including that anybody shopping for compounded medicine from a doubtful supply runs the chance of utilizing drugs 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 folks 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 is perhaps keen to compromise security in pursuit of revenue.
Plus, he says, individuals who purchase weight reduction drugs on a budget aren’t sometimes getting the dietary counseling to be certain that they’re staying wholesome when drastically chopping energy.
“Meals as medication is a crucial element right here,” Kraftson says. “Anybody might shed extra pounds 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 are actually promoting semaglutide and tirzepatide within the type of a tablet or liquid. These substances, purportedly utilizing the identical lively elements which are present in Wegovy and Zepbound, aren’t swallowed however as a substitute dissolve beneath the tongue. That is known as sublingual supply.
Are sublingual GLP-1 capsules and liquid suspensions authorized? Compounding pharmacies are allowed to vary the type of prescription drugs for sufferers when a health care provider has indicated that “the commercially obtainable remedy shouldn’t be applicable,” says Tenille Davis, PharmD, the chief advocacy officer on the Alliance for Pharmacy Compounding. For sufferers with a extreme worry of needles or allergic reactions to inactive elements in injectable options, sublingual administration provides an answer. However there has by no means been any printed 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 could be absorbed within the oral cavity by dissolvable tablets or tinctures positioned beneath the tongue. However different specialists are skeptical, warning that it’s probably 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 beneath our tongue and have it work the identical means.”
Some Compounded Medicine Are Riskier Than Others
Simonetti empathizes with sufferers who’re desperately attempting to entry these weight reduction drugs.
“I perceive individuals are determined and the way the choice rolls round to decide on these drugs from a compounded pharmacy,” she says.
If somebody does select to buy compounded semaglutide, Simonetti provides just a few bits of recommendation to make sure the absolute best security. First, she recommends checking the FDA’s checklist 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 checklist 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 folks to seek for pharmacies by their web site to weed out ones which are fraudulent.
Discover our suggestions for the finest on-line GLP-1 applications, together with Henry Meds, Discovered, and Noom Med.
Folks ought to at all times ask the producer for details about what number of milligrams of lively elements are in every dose. Although the exact nature of those elements could also be a thriller, having at the least an thought of how a lot semaglutide-like substance is in every dose will help clinicians assist their sufferers with food regimen and medicine administration.
“Lots 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 elements.”
If you happen to 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 folks 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 needs to be keen to supply a certificates of purity that claims that the medication is pure and sterile.
“If the pharmacist is hesitant to debate these sorts of issues, I might select one other pharmacy,” she says.
Watch out for Unlawful GLP-1 Medicine
Whereas compounding pharmacies could appear to be working in a regulatory grey space, different on-line suppliers have interaction in definitively unlawful practices. A latest survey of the net market recognized greater than 100 web sites claiming to promote semaglutide that may be ordered with out a prescription. Pharmacies can not legally present GLP-1 medicine with out 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 extra money: They had been outright scams. The opposite three suppliers did ship some medication containing semaglutide, however lab exams 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 drugs 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 specialists are nervous about off-brand Ozempic and related merchandise. Whereas the FDA has not assessed the security or efficacy of any compounded medicine, you’ll be able to take steps to cut back the dangers of shopping for weight reduction medicine on-line.
