Compounded weight loss drugs: Is the low cost worth the risk?

Compounded weight loss drugs: Is the low cost worth the risk?

Using compounded drugs as a cheaper alternative to medicines like Ozempic® or Mounjaro® can be risky—and health professionals are sounding alarms.

Kaitlyn Dykman
July 31, 2023
5 min read
Table of Contents
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The most popular drugs used for weight loss—like Ozempic®,  Wegovy® or Mounjaro® are often expensive: Paying for the brand name drugs out of pocket can cost around $1,000 a month.

There are no generic versions of these medications because they are under patent—and coupon programs can be limited. So many people, eager to lose weight and get around the hefty price tag, turn to compounding pharmacies that claim to recreate the synthetic hormone in these brand-name medications. While patients might pay around $900 monthly for Ozempic and $1,300 monthly for Wegovy out-of-pocket, they could find compounded semaglutide for as little as $300 a month.

But what exactly are they getting? And is the compounded medication as effective or as safe as the brand-name product?

Eli Lilly, the company that manufactures Mounjaro and the newly FDA-approved weight loss drug Zepbound™, is, according to a news release, “extremely concerned” that some of the compounded tirzepatide they tested “contained high amounts of impurities, and, in at least one instance, was actually nothing more than sugar alcohol.”

Other health care organizations and professionals are also concerned. In January, three organizations, the Obesity Medicine Association, the Obesity Action Coalition, and The Obesity Society, issued a joint statement saying, “Unfortunately, many of the available alternatives, like compounded versions of semaglutide and tirzepatide, are not what they are advertised to be.”

And even the U.S. Food and Drug Administration (FDA) has issued warnings about compounded drugs being sold as alternatives to brand-name prescription medications. The FDA doesn’t review compounded versions of these weight loss drugs, and cautions “patients should not use a compounded drug if an approved drug is available.” 

First, what does “compounded” mean? 

According to the FDA, "compounding” is when a pharmacist or compounding pharmacy combines, mixes, or alters ingredients to create a medication for a patient rather than using a drug as-is from a manufacturer. When a drug appears on the FDA’s drug shortages list, compounded versions of it can be made and distributed with fewer restrictions.

Compounded semaglutide may be made with different synthetic versions of semaglutide—such as semaglutide sodium salt or semaglutide acetate—and/or combined with other ingredients by compounding pharmacies.

And while compounded medications are advertised as cheaper alternatives, the FDA does not approve or vet them for safety or efficacy. In fact, the FDA recently issued a warning advising consumers not to use a compounded drug if an approved one is available.

Backing up: What is semaglutide, and how does it work? 

Semaglutide is a GLP-1 (short for glucagon-like peptide-1) receptor agonist that’s FDA-approved to treat type 2 diabetes or obesity under different dosages and brand names. The pharmaceutical company Novo Nordisk produces semaglutide under the brand names Ozempic, Wegovy, and Rybelsus®.

GLP-1 receptor agonists like semaglutide mimic your body’s natural GLP-1 incretin hormone, which helps increase insulin secretion and reduce glucagon secretion. In other words, GLP-1s help lower your blood sugar levels. GLP-1 receptor agonists also slow gastric emptying (digestion), help suppress appetite signals, and reduce hunger, which can help users feel fuller after meals.

Even these FDA-approved medications have the potential for minor and more serious side effects. Common side effects include nausea, vomiting, diarrhea, and acid reflux. More serious but less common side effects include pancreatitis, gallbladder disease, and worsening of diabetic eye disease. You should not use these drugs if you have a personal or family history of medullary thyroid cancer or multiple endocrine neoplasias. You can find detailed side effect and risk information for specific GLP-1 medications here.

So, what’s in compounded semaglutide? 

According to the FDA, semaglutide is only approved for use in its base form, which is made by Novo Nordisk. Which begs the questions: Where are compounding pharmacies getting their semaglutide, and is it really semaglutide? It’s hard to say. According to Novo Nordisk, the company doesn’t share the drug’s active ingredient with compounding pharmacies.

As Pharmacy Times explains, “often what is being compounded is not semaglutide, but the sodium salt that is not FDA-approved.” More recently, the FDA stated in a letter that some compounding pharmacies may be producing compounded semaglutide using semaglutide sodium salt or semaglutide acetate—and that the FDA is not aware of any basis for compounding a drug with these ingredients that would meet “federal law requirements.” 

“Patients should only obtain drugs containing semaglutide with a prescription from a licensed health care provider, and only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with FDA,” the FDA advised in a recent warning about compounded semaglutide following reports of adverse events in people who used compounded versions.

Rekha Kumar, MD, Found’s Head of Medical Affairs and former medical director of the American Board of Obesity Medicine, puts it this way: “The only manufacturer of semaglutide is Novo Nordisk, and it’s under patent. Any semaglutide that’s not brand name Ozempic, Rybelsus®, or Wegovy is not FDA-approved.”

Is compounded semaglutide safe to use?

Although compounded drugs, in general, are legal, they are not FDA-approved or regulated in the same way—meaning they may not have the same safety, quality, and effectiveness as FDA-approved drugs. It can be hard to know where—or how—the compounded formulations were made or what exactly is in them. Because of this, there are potential risks:

  • Contamination of bacteria and fungus—often from poor compounding practices.
  • Too much or too little of the active ingredient—often from poor compounding practices.
  • Unknown side effects—Novo Nordisk hasn’t conducted studies to evaluate the safety and efficacy of its approved GLP-1s when compounded with other ingredients. 
  • Unverified ingredients—The additional ingredients in compounded drugs can’t be verified. 

All of these risks can lead to injury or death.

Despite these risks, high prices and a short supply of branded GLP-1s are driving a rise in online telehealth and local weight-loss clinics selling compounded GLP-1s. Additionally, not all clinics consider patients’ medical history when prescribing a compounded GLP-1 or follow their progress on the medication. So, although they may offer initial savings, compounded GLP-1s may not be worth the risks.

Considering prescription weight-loss medication? Here’s what to look for: 

Prescription weight-loss medication can be effective when healthcare providers prescribe it responsibly. But it’s important to ask questions and know what’s in the medication you are prescribed, says Dr. Kumar.

“If someone is interested in semaglutide, they should ask if it is the brand Wegovy or Ozempic or Rybelsus,” she says. “If the price seems too good to be true, I would be concerned.”

Even brand name drugs have risks 

It’s important to work with a health care provider who is trained in obesity medicine—they can personalize a prescription for you, using drugs that have been approved by the FDA for weight loss or approved for other indications and have demonstrated clinical effectiveness for weight loss.

A Found provider can monitor your progress throughout your weight journey, and change your prescription as your needs change.

While brand-name medications have been approved by the FDA, it’s important to understand there are still risks. GLP-1 and GLP-1/GIP medications have some known potential side effects. The most common are nausea, vomiting, diarrhea, and acid reflux. More serious but less common side effects include pancreatitis, gallbladder disease, and worsening of diabetic eye disease. And those with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasias should not use them. Find detailed side effect and risk information for specific medications by name on our dedicated medication page.

About Found

Found is a clinician-led online weight management program that addresses biology’s role in weight. At Found, providers are specifically trained in obesity medicine, and medications they prescribe are FDA–approved for at least one indication, such as diabetes or obesity. Found’s toolkit of medication options includes a variety of brand-name GLP-1s, as well as generic medications, such as naltrexone and topiramate. Found health care providers help determine whether medication is right for each member and develop a personalized plan. Members also receive check-ins at critical moments on their journey and behavior change guidance and social support within a mobile app. To start your journey with Found, take the quiz.

About the author, Kaitlyn Dykman

Kaitlyn Dykman is a certified health education specialist, a women’s holistic hormone health practitioner, and a former Found coach who writes about health and medicine at Found.

Published date:
July 31, 2023
Meet the author
Kaitlyn Dykman
Health writer

Sources

  • Research, U.S. Food and Drug Administration. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
  • Product Supply Information | Wegovy® (semaglutide) Injection 2.4 mg. (n.d.). novoMEDLINK. https://www.novomedlink.com/obesity/products/treatments/wegovy/resources/product-supply-information.html
  • Wegovy Supply. (n.d.). Novo Nordisk. https://www.novonordisk-us.com/supply-update.html
  • Latif W, Lambrinos KJ, Rodriguez R. Compare and Contrast the Glucagon-like Peptide-1 Receptor Agonists (GLP1RAs) [Updated 2022 Mar 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK572151/
  • Research, U.S. Food and Drug Administration. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss
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