Understanding the new landscape of unregulated Semaglutide

Comparing Ozempic, Wegovy, and Compounded Alternatives

Have you recently scrolled through TikTok or Facebook and noticed influencers or ads promoting easy access to surprisingly low-cost semaglutide, without even a physical doctor visit? If so, you’re right to wonder what’s behind these promotions. The average price for a month’s supply of the prescription medications is about $1,200. Yet some of these ads promote alternatives as low as $400 a month — with just a quick telehealth visit. What’s up?

As the demand for semaglutide soars, fueled by stories of rapid results, the market is adjusting to meet demand. This gives rise to new compounded, off-brand versions of popular drugs like Ozempic and Wegovy. This article will help explain the current, complex landscape of semaglutide options, comparing FDA-approved options with the risks associated with unofficial versions flooding the market — and your social media platforms. Here’s what you need to know to stay informed.

What is Semaglutide?

Semaglutide, a medication belonging to the class of glucagon-like peptide-1 (GLP-1) receptor agonists, is recognized for its effectiveness in managing type 2 diabetes and also, as a happy side-effect, aiding in weight loss by regulating blood sugar, slowing stomach emptying and gastric motility, and changing the brain’s response to hunger cues in ways we still don’t fully understand. Its two FDA-approved forms, Ozempic and Wegovy, have gained considerable attention, not only for their benefits, but also due to supply shortages, leading to the emergence of compounded — and even counterfeit — alternatives.

FDA-Approved Semaglutide Products

Ozempic and Wegovy, produced by Novo Nordisk, are the only FDA-approved semaglutide products currently available on the market as of this writing (though many more are in the pipeline). Ozempic is approved to lower blood sugar levels and reduce the risk of major cardiovascular events in adults with Type 2 diabetes, while Wegovy is approved to manage obesity in adults and children over 12. Both require a prescription and should ideally be sourced from licensed pharmacies to ensure their authenticity, quality and safety.

Concerns with Counterfeit and Compounded Semaglutide

Counterfeits: The FDA has recently issued warnings regarding counterfeit Ozempic found in the U.S. drug supply. These counterfeits, identifiable by specific lot and serial numbers, pose significant health risks due to potential contamination and incorrect formulation. Consumers are urged to verify product authenticity and report any adverse effects to the FDA’s MedWatch program.

Compounded alternatives: Compounded semaglutide products are also available. These are not FDA-approved. The active ingredient in FDA-approved semaglutide products like Ozempic and Wegovy is semaglutide in its base form, and has been prepared for dosage using proprietary methods, using sterile pen-style injectors. The sodium or acetate salts of semaglutide, which are used in some compounded medications, have not been approved by the FDA for humans. This means they have not undergone the rigorous testing and review process that ensures a drug is safe and effective for public use. The legality of these variants is a gray zone.

The lack of FDA oversight and evaluation means that potential side effects and adverse reactions may be broader than with official versions and not well understood. Patients using compounded semaglutide formulations could be at risk of unexpected side effects, particularly if the compound’s purity, potency, or stability differs from the approved product.

There is also the risk that these compounds may not be as effective as the FDA-approved form of semaglutide, potentially leading to inadequate treatment of the conditions for which semaglutide is prescribed, such as diabetes. Or even hypoglycemia or stronger gastrointestinal distress if the potency is higher or the response curve is different.

Legal and Health Risks of Non-FDA Approved Semaglutide

Compounded semaglutide products are generally considered “unapproved” therapeutic goods. They are only possible to buy — and should only be considered for use — when FDA-approved alternatives are not available or suitable, which is currently the situation due to Ozempic and Wegovy’s shortages. Patients and healthcare providers must be aware that using or prescribing these compounded medications can lead to potential health risks and legal liabilities, and the reported incidents of complications are higher with these variants.

Advice for Consumers

1. Purchase from Licensed Pharmacies: Obtain semaglutide through a licensed pharmacy to ensure you receive an FDA-approved product.
2. Verify Product Details: Check the packaging and labeling for signs of counterfeiting. Refer to FDA communications for specific identifiers of counterfeit products.
3. Consult Healthcare Providers: Discuss your specific health needs and potential medication options with your doctor or pharmacist. They can provide guidance on the use of approved medications and the risks associated with compounded alternatives.
4. Report Adverse Effects: If you experience any side effects from semaglutide, report them immediately to FDA’s MedWatch program. This will help the FDA track bad lots or counterfeits.
5. Be Skeptical of Online Offers: Be cautious of websites or services offering semaglutide without a prescription or proper verification, or for suspiciously low prices. Check against the National Association of Boards of Pharmacy’s list of fraudulent and unsafe providers.

Caveat Emptor

While FDA-approved semaglutide products like Ozempic and Wegovy are tested and proven for safety and efficacy, the same cannot be said for compounded or counterfeit versions. American consumers should remain vigilant, seeking information and products from reliable, licensed sources and consulting with healthcare professionals to ensure their safety and the effectiveness of their treatments.

You have options

Did you know that roughly 80% of people who begin Semaglutide treatment stop using it within 2 years? Weight regain is also a concern for most users who cease treatment. While the iDiet program is not as effective as an injectable, iDiet’s use of fiber, careful dietary formulation, and good lifestyle practices, does provide many of the same end results — including lower hunger, greater satiety, less “food noise”, and a greater sense of control. Injectables can provide extremely rapid results, but at the cost of muscle loss and osteoporosis. iDiet targets a safe, healthy rate of weight loss that is intended to not impact lean body mass or bone density.