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 Way of life Drugs
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 protected 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 provide 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 “do-it-yourself” 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 stories of unanticipated well being issues in folks utilizing the treatment.
It’s a threat many individuals seem keen to absorb their quest to shed pounds.
When Insurance coverage Gained’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 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 youngsters, 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 issues). 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. “But it surely 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 known 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 individuals who are obese and have not less than one weight-related situation, reminiscent of 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 different to Wegovy: compounded semaglutide, obtainable by a nurse who advised Sunnie she was reselling it from a compounding pharmacy. A couple of coworkers have been taking the treatment with success, so Sunnie determined to go for it, shopping for a month’s provide for lower than $300.
“I perceive there’s threat. I do know it could possibly 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 want treatment to assist me.”
Sunnie began shedding 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 treatment, 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 whole lot 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 the USA concentrate on compounding.[2] These pharmacies combine, alter, or mix FDA-approved medicine with completely different substances for folks with explicit wants, reminiscent of people who could also be allergic to a sure dye within the brand-name treatment.
If there’s a scarcity of a drug, compounded variations grow to be authorized in the USA. In Could 2023, the FDA included each Ozempic and Wegovy on its drug shortages record, legalizing compounded variations of the medicine.
The FDA acknowledges that compounded medicine can fill an necessary want, however it additionally warns that they “pose the next threat to sufferers than FDA-approved medicine as a result of they don’t endure 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 obtainable.
No generic type of semaglutide exists, although compounded medicine are sometimes marketed as such. The corporate has filed not less than 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 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 protected and efficient in scientific trials. The FDA has obtained stories of opposed results from individuals who take compounded semaglutide.
Pharmacies promoting compounded semaglutide typically embody nutritional vitamins reminiscent of 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 usually deny protection for injectable weight reduction medicine to folks with weight problems, even for sufferers who’ve used these medicines to get prediabetes below management. She understands what’s driving folks to hunt alternate options.
However, she says, there isn’t a 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 danger 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 load navigation program at Michigan Drugs 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 could 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 reducing energy.
“Meals as drugs is a crucial element right here,” Kraftson says. “Anybody may shed pounds on 800 energy a day within the type of Twinkies, however 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 energetic substances which might be present in Wegovy and Zepbound, will not be swallowed however as an alternative dissolve below the tongue. That is known as sublingual supply.
Are sublingual GLP-1 capsules and liquid suspensions authorized? Compounding pharmacies are allowed to alter the type of prescription medicines for sufferers when a physician has indicated that “the commercially obtainable treatment isn’t applicable,” 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 provides an answer. However there has by no means been any revealed examine of sublingual GLP-1s, and the security and efficacy of such substances could also be extraordinarily questionable.
Dr. Davis says that not less than one massive compounding pharmacy has carried out in-house research displaying that semaglutide salts might be absorbed within the oral cavity by dissolvable tablets or tinctures positioned below the tongue. However different specialists are skeptical, warning that it’s possible that solely small quantities of the energetic ingredient are absorbed this manner.
“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 approach.”
Some Compounded Medicine 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 provides a number of bits of recommendation to make sure the absolute best security. First, she recommends checking the FDA’s record of licensed compounding pharmacies.
“This can be a good place to start out. You continue to don’t know what you might be getting, however going with an organization on this record reduces the danger that you simply’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 enables folks to seek for pharmacies by their web site to weed out ones which might be fraudulent.
Discover our suggestions for the finest on-line GLP-1 applications, together with Henry Meds, Discovered, and Noom Med.
Individuals ought to at all times 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 not less than an thought of how a lot semaglutide-like substance is in every dose may also help clinicians help their sufferers with food regimen and medicine administration.
“A whole lot of compounded medicine are available in models,” 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 folks 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 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 interact in definitively unlawful practices. A current survey of the web market recognized greater than 100 web sites claiming to promote semaglutide that may be ordered with no prescription. Pharmacies can not 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 energetic ingredient was included in inaccurate concentrations. One of many samples was contaminated with endotoxin and will 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 specialists are nervous about off-brand Ozempic and comparable merchandise. Whereas the FDA has not assessed the security or efficacy of any compounded medicine, you possibly can take steps to scale back the dangers of shopping for weight reduction medicine on-line.
