The FBI has issued a public warning about counterfeit compounded weight-loss drugs being sold under the guise of containing semaglutide, the active ingredient in the popular prescription medications Ozempic and Wegovy. These counterfeit drugs, which are being sold by noncompliant healthcare providers—including weight loss clinics, medical spas, and pharmacies—pose significant health risks.
Health Risks of Counterfeit Semaglutide Drugs
The FBI’s notice outlines the dangers of taking fraudulent versions of semaglutide. These misrepresented drugs have been found to contain a mix of unknown substances, high levels of impurities, and unsafe or unapproved drugs. The potential health consequences are severe and include cardiac and gastrointestinal disorders, nervous system disorders, psychiatric disorders, and, in some cases, death.
In one troubling example, a medical spa and weight loss clinic in the South sold a compounded medication that claimed to contain semaglutide but was instead found to contain animal-grade semaglutide mixed with vitamin B12—well below the quality standards set by the U.S. Food and Drug Administration (FDA). This practice is a significant violation of FDA regulations and puts unsuspecting consumers at risk.
The FBI’s Advice to Consumers
The FBI strongly advises consumers to avoid purchasing weight-loss drugs from unlicensed healthcare providers, particularly those offering suspiciously low prices. The agency emphasizes that patients should only buy medications from licensed pharmacies and consult with a healthcare provider before starting any weight-loss medication.
Drug compounding, which involves creating medications that are tailored to individual patients’ needs, is permissible in certain cases. However, compounded drugs are not approved or inspected by the FDA, making them a less regulated and potentially risky option. Compounded versions of semaglutide, like those in question, are only legal when prescribed by a doctor in situations where FDA-approved versions are unavailable or unsuitable.
The Role of Compounded Medications and the FDA’s Actions
A surge in demand for weight-loss medications over the past few years has led to drug shortages. However, the FDA recently declared these shortages resolved, removing Ozempic and Wegovy from its shortage list. Following this, the FDA has issued a timeline for the cessation of compounded versions of semaglutide, which will be phased out in most state-licensed pharmacies by April 22, 2025, and by May 22, 2025, in larger outsourcing pharmacies.
The FDA also emphasized that compounded semaglutide requires a prescription and must be made by licensed pharmacies following strict standards.
What Are Ozempic and Wegovy?
Ozempic is an FDA-approved medication for the treatment of Type 2 diabetes, but many doctors also prescribe it off-label for weight loss. Wegovy, which contains the same active ingredient (semaglutide), is FDA-approved specifically for weight loss in individuals with obesity or those who are overweight with at least one weight-related condition. Additionally, Wegovy is approved to reduce the risk of major cardiovascular events in adults with obesity or established cardiovascular disease.
Semaglutide works by slowing down the movement of food through the stomach and curbing appetite, which ultimately leads to weight loss.
Conclusion
The FBI’s warning about counterfeit semaglutide drugs highlights the risks of purchasing medications from unregulated sources. As weight-loss drugs like Ozempic and Wegovy gain popularity, it is more important than ever for patients to be cautious and only use medications prescribed by a licensed healthcare provider. With compounded versions of semaglutide being restricted, patients should be aware of the potential dangers associated with unapproved treatments and seek professional guidance before starting any weight-loss regimen.
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