Alarmingly, Many Websites Mislead Customers About Compounded Diabetes and Weight Loss Medications

A recent study has uncovered concerning practices on websites selling compounded versions of popular medications for diabetes and weight loss, such as Ozempic and Wegovy. According to a research letter published in JAMA Health Forum, more than a third of these websites falsely claim that the compounded medications have received FDA approval. This misrepresentation poses significant risks to consumers who may unknowingly purchase unregulated and potentially harmful products.

Understanding Compounded Medications

Compounded medications, which use the same active ingredients as FDA-approved drugs like Ozempic and Wegovy, are not subject to the same regulatory scrutiny. These drugs are typically used during drug shortages, when patients have allergies to certain dyes, or when they require a different formulation, such as a liquid instead of a pill. However, they may contain varying amounts of active ingredients or pose contamination risks, as they are not FDA-approved.

Study Findings

A cross-sectional study conducted between July and September 2024 evaluated 98 websites selling glucagon-like peptide 1 receptor agonists (GLP-1 RAs). Seventy-nine of these websites offered compounded GLP-1 RAs. The study revealed several alarming trends:

• All 79 websites selling compounded GLP-1 RAs offered compounded semaglutide.
• Fifty-seven (72%) of these websites sold compounded tirzepatide.
• Three (3.8%) sold compounded liraglutide.

Eleven websites, almost 14%, failed to disclose that the GLP-1 RAs they sold were compounded. Seven websites, nearly 9%, incorrectly referred to these medications as generics, which they are not. Thirty-four websites, 43%, explicitly stated that compounded medications are not FDA-approved. However, a concerning 29 websites, 36.7%, claimed or implied FDA approval.

Misinformation and Risk

The study also found that 39 websites, 49.4%, did not report adverse effects, precautions, warnings, and contraindications of compounded GLP-1 RAs. Additionally, 32 websites, 40.5%, made unsubstantiated claims about the effectiveness of these medications, often asserting benefits not supported by FDA-approved labels. For instance, some websites claimed that the medications would improve sexual function or promote hair growth.

“One of the major findings was that many of these websites did not disclose that compounded GLP-1 RAs are not FDA-approved, and some suggested that they are,” explained first author Ashwin Chetty, a second-year medical student at Yale School of Medicine. “This is concerning because patients need to understand what a compounded drug is.”

Regulatory Implications

The FDA mandates that all prescription drug advertising, including compounded medications, must be truthful, accurate, and not misleading. The lack of transparency and misinformation on these websites can mislead patients about the risks and benefits of compounded GLP-1 RAs.

Chetty emphasized, “That ultimately gives an incomplete and incorrect picture to patients and consumers.” Alissa Chen, MD, a postdoctoral fellow at Yale School of Medicine and a primary care physician, added, “It leaves the potential for patients to become misinformed about what they can gain from taking a GLP-1 RA.”

What Healthcare Providers Should Know

Physicians play a crucial role in educating patients about the differences between FDA-approved and compounded medications. Chen urged, “Physicians need to help their patients understand the basics of FDA approval.” She suggested that doctors approach patients with empathy, listening to their concerns and understanding their reasons for seeking compounded medications.

Another important responsibility for healthcare providers is to be aware of patients’ current medication regimens, especially if patients are taking GLP-1 RAs prescribed elsewhere.

Cost Considerations

Compounded GLP-1 RAs are often much cheaper than FDA-approved versions, which are typically expensive and may not be covered by insurance. Patients might be tempted by the lower cost, but the trade-off in safety and efficacy could be significant.

Future Directions

Chetty expressed a desire for the FDA to issue clearer guidelines on the marketing of compounded drugs. He also proposed that future research could investigate the level of clinician involvement necessary to obtain compounded GLP-1 RAs.

“Relying only on the information provided on these websites is not all the information you should have to make that decision,” Chetty said.

Conclusion

Consumers should approach websites selling compounded diabetes and weight loss medications with caution. Misleading claims about FDA approval and unsubstantiated health benefits can lead to poor health outcomes. It is crucial for individuals to consult with healthcare providers before taking any compounded medication.

Healthcare providers should be vigilant about educating patients and monitoring their use of compounded drugs. By working together, we can ensure that patients receive the accurate information and care they need.

Have you encountered misleading information about compounded medications? Share your thoughts in the comments below.

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