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 Medication
Demand for Ozempic, Wegovy, Zepbound, and Mounjaro has led to the rise of on-line corporations 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 protected 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 corporations 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 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 reviews of unanticipated well being issues in individuals utilizing the treatment.
It’s a threat many individuals seem prepared to absorb their quest to drop some weight.
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 youngsters, 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 needs and impulses within the mind,” says Sunnie. “Nevertheless 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 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 at the least one weight-related situation, comparable 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 couple of cheaper different to Wegovy: compounded semaglutide, out there by means of 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 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 belief that I want treatment to assist me.”
Sunnie began dropping pounds shortly, and observed 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 numerous 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 the US concentrate on compounding.[2] These pharmacies combine, alter, or mix FDA-approved medication 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 treatment.
If there’s a scarcity of a drug, compounded variations change into authorized in the US. In Could 2023, the FDA included each Ozempic and Wegovy on its drug shortages checklist, legalizing compounded variations of the medication.
The FDA acknowledges that compounded medication can fill an necessary want, nevertheless it additionally warns that they “pose the next threat to sufferers than FDA-approved medication as a result of they don’t bear FDA premarket overview 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 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 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 medical trials. The FDA has acquired reviews of opposed results from individuals who take compounded semaglutide.
Pharmacies promoting compounded semaglutide typically embrace nutritional vitamins comparable to B12 within the combine to allegedly increase weight reduction, a declare for which there is no such thing as a strong proof.[5]
Compounded Semaglutide and Tirzepatide Are Too Dangerous, Specialists 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 corporations so usually deny protection for injectable weight reduction medication to individuals with weight problems, even for sufferers who’ve used these drugs to get prediabetes underneath management. She understands what’s driving individuals to hunt options.
However, she says, there is no such thing as a technique to know for positive the situations that compounded medication are created in, including that anybody shopping for compounded medication from a doubtful supply runs the chance of utilizing drugs 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 persons are scrambling to get the medication. He factors out that weight problems is very 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 is perhaps prepared to compromise security in pursuit of revenue.
Plus, he says, individuals who purchase weight reduction drugs on a budget aren’t usually getting the dietary counseling to be sure that they’re staying wholesome when drastically chopping energy.
“Meals as drugs is a vital part right here,” Kraftson says. “Anybody might drop some weight 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 tablet or liquid. These substances, purportedly utilizing the identical energetic substances which are present in Wegovy and Zepbound, are usually not swallowed however as a substitute dissolve underneath 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 drugs for sufferers when a physician has indicated that “the commercially out there treatment isn’t applicable,” says Tenille Davis, PharmD, the chief advocacy officer on the Alliance for Pharmacy Compounding. For sufferers with a extreme concern of needles or allergy symptoms to inactive substances in injectable options, sublingual administration presents an answer. However there has by no means been any revealed research of sublingual GLP-1s, and the protection 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 exhibiting that semaglutide salts could be absorbed within the oral cavity by means of dissolvable tablets or tinctures positioned underneath 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 suppose 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 underneath our tongue and have it work the identical manner.”
Some Compounded Medicine Are Riskier Than Others
Simonetti empathizes with sufferers who’re desperately attempting to entry these weight reduction drugs.
“I perceive persons 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 presents just a few bits of recommendation to make sure the very best security. First, she recommends checking the FDA’s checklist of licensed compounding pharmacies.
“It is a good place to begin. You continue to don’t know what you’re 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 underneath the pores and skin,” she says.
The Nationwide Affiliation of Boards of Pharmacy additionally has a database that enables individuals 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 energetic substances are in every dose. Although the exact nature of those substances could also be a thriller, having at the least an concept of how a lot semaglutide-like substance is in every dose can assist clinicians support their sufferers with eating regimen and medicine administration.
“Numerous compounded medication 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.”
For those who can discuss 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 needs to be prepared 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’d 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 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’t legally present GLP-1 medication 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 a substitute demanded more cash: They have been outright scams. The opposite three suppliers did ship some drugs 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 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 medication, however most consultants are nervous about off-brand Ozempic and related merchandise. Whereas the FDA has not assessed the protection or efficacy of any compounded medication, you possibly can take steps to cut back the dangers of shopping for weight reduction medication on-line.
