As weight loss drugs soar in popularity, many people are turning to cheaper alternatives to the expensive brand-name versions like Ozempic and Wegovy. One such alternative is compounded semaglutide, a medication that mirrors the active ingredients in these costly treatments but comes with questions about its safety and efficacy. The rise of compounded versions of GLP-1 medications—such as semaglutide—has sparked both excitement and concern, especially as companies like Hims & Hers market them as a more affordable solution to what they call a “sick system.”
What is Compounded Semaglutide?
Compounded semaglutide is a legal, but unregulated, version of the active ingredient found in drugs like Ozempic and Wegovy. In general, compounding pharmacies are allowed to create copies of medications under special circumstances, such as when there is a shortage of a specific drug. These pharmacies are required to follow strict guidelines when reproducing the formula of brand-name drugs, but the resulting product is not subject to the same rigorous testing and oversight by the Food and Drug Administration (FDA).
While compounded semaglutide can be sold at a lower price point—often administered via a syringe rather than the brand-name injector pens—it differs from FDA-approved versions not only in its regulation but also in how it is delivered to patients.
The Surge in Demand for Semaglutide
Semaglutide has been available for two decades but gained significant attention when it was approved in 2021 for chronic weight management. However, both Novo Nordisk (the maker of Ozempic and Wegovy) and Eli Lilly (Mounjaro and Zepbound) have struggled to meet the high demand for these medications, leading to supply shortages that have persisted since early 2022. With shortages still impacting the availability of the brand-name drugs, compounded versions have emerged as a solution, though their safety remains a contentious issue.
Compounding pharmacies are permitted to manufacture these medications when shortages occur, and the end of shortages could affect the legality and availability of compounded alternatives. Despite the return of some brand-name drugs to market, many telehealth companies continue to offer compounded semaglutide as a lower-cost option, making it more accessible to a broader audience.
Why Are People Choosing Compounded Semaglutide?
The primary allure of compounded semaglutide is its price. The cost of brand-name weight loss medications can be prohibitive, with Ozempic priced at over $1,000 per month without insurance. In contrast, compounded versions can be significantly cheaper. For example, telehealth services like Hims & Hers advertise compounded semaglutide starting at $165 for a monthly supply. This price difference has made the drug attractive to many looking for a more affordable weight loss solution.
However, the low cost also comes with risks. Unlike FDA-approved medications, compounded semaglutide is not subjected to the same stringent safety checks. The process for administering the drug can also lead to errors. Unlike the carefully calibrated injector pens used for brand-name medications, compounded semaglutide is administered through a syringe, making it easier for patients to administer incorrect doses, potentially leading to dangerous overdoses.
Safety Concerns Surrounding Compounded Semaglutide
Regulators and health experts have raised alarms about the safety of compounded semaglutide. The FDA has issued warnings about potential impurities in the drug, concerns about the unapproved salts used in the formula, and reports of adverse events, including hospitalizations and deaths. According to data from Novo Nordisk, there were 442 reported cases of adverse events linked to compounded semaglutide as of March 2024, including 99 hospitalizations and seven fatalities.
While compounded medications are not inherently unsafe, they are not subject to the same oversight as FDA-approved drugs. This lack of regulation leaves patients exposed to potentially harmful substances, and the risks of overdose are significant. Some users have received doses of semaglutide up to 20 times higher than what they should have taken, resulting in severe side effects like vomiting and other complications.
The Rise of Counterfeit Medications
Compounded semaglutide is not the only concern in the world of weight loss drugs. The growing popularity of medications like Ozempic has led to a surge in counterfeit products. According to a recent study, nearly half of online pharmacies selling “semaglutide” are illegal operations that do not require prescriptions and offer unregulated products. These counterfeit drugs may contain harmful substances or incorrect dosages, further compounding the risks for consumers.
How to Ensure Safe Use of Semaglutide
The safest way to use semaglutide is through FDA-approved medications, such as Ozempic, Wegovy, Mounjaro, or Zepbound. If compounded semaglutide is the only option available, it is crucial to ensure that it is being obtained from a reputable pharmacy. Patients should inquire about the compounding pharmacy’s FDA registration, ask whether third-party testing is done on the medications, and confirm the accuracy of the doses. Additionally, all prescriptions for semaglutide should come from licensed healthcare providers, and patients should be cautious of websites offering medications without proper medical oversight.
As weight loss drugs continue to dominate the healthcare landscape, it’s clear that more affordable options are in high demand. However, consumers must be vigilant about where they obtain their medications and the potential risks involved. The promise of cheaper semaglutide may seem enticing, but the safety of these treatments is not guaranteed, and they may not always be the best option for those seeking effective, reliable weight loss solutions.
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