The U.S. Food and Drug Administration (FDA) is intensifying its efforts to regulate unapproved versions of GLP-1 receptor agonists, including semaglutide and tirzepatide, widely used for weight loss. As these drugs gain popularity, unapproved compounded versions are flooding the market, raising concerns about safety, efficacy, and quality control. At Sterling Medical Center, we emphasize the importance of using only FDA-approved medications and urge patients to be vigilant when considering weight loss treatments.
The Rise of GLP-1 Drugs for Weight Loss
GLP-1 (glucagon-like peptide-1) receptor agonists work by regulating blood sugar levels and appetite, making them highly effective for weight management. FDA-approved versions of these drugs have been rigorously tested in clinical trials to ensure safety and efficacy. However, with increased demand and supply shortages, many patients are turning to compounded or unapproved alternatives—options that may pose significant health risks.
Why Compounded GLP-1 Drugs Are Risky
Lack of FDA Oversight and Quality Control
Compounded medications are formulated in pharmacies that customize drugs based on individual patient needs. However, compounded GLP-1 drugs do not undergo FDA approval, meaning their safety, effectiveness, and consistency are not guaranteed. These versions may contain incorrect dosages, impure ingredients, or ineffective formulations that could compromise patient health.
Adverse Events and Safety Concerns
The FDA has received multiple reports of adverse effects associated with compounded semaglutide and tirzepatide, including:
- Severe gastrointestinal distress: Nausea, vomiting, diarrhea, and abdominal pain.
- Dosing errors: Incorrect self-administration and miscalculations by healthcare professionals.
- Unregulated formulations: Some compounded versions contain unknown ingredients or incorrect active compounds, leading to unpredictable effects.
As of February 28, 2025, the FDA has documented over 455 adverse event reports related to compounded semaglutide and more than 320 cases linked to compounded tirzepatide. The actual number of incidents may be much higher, as state-licensed pharmacies are not required to report all adverse events.
Concerns Over Salt Forms of Semaglutide
Some compounders are using alternative chemical forms of semaglutide, such as semaglutide sodium and semaglutide acetate. These salts are not the same as the active ingredient in FDA-approved versions and have not been proven to work safely or effectively. The FDA has explicitly stated that these altered forms should not be used for compounding, as their pharmacological effects remain unverified.
The Danger of Counterfeit and Illegally Marketed GLP-1 Drugs
Counterfeit Ozempic and Other Unapproved Versions
The FDA is investigating reports of counterfeit Ozempic being sold in the U.S. Counterfeit medications pose serious risks because they may:
- Contain harmful or ineffective ingredients.
- Have incorrect dosages that lead to serious side effects or lack of efficacy.
- Be manufactured without quality control, increasing contamination risks.
Illegally Sold Online GLP-1 Products
Online pharmacies and unlicensed sellers are distributing unapproved semaglutide, tirzepatide, and retatrutide, falsely labeling them as “for research purposes” or “not for human consumption.” These products are often misleadingly marketed with dosing instructions, encouraging unauthorized use.
Retatrutide: A Non-Approved Compound Not for Human Use
Retatrutide, a newer GLP-1 drug under investigation, cannot legally be compounded or used for weight loss. It has not received FDA approval, and its safety profile remains unestablished. Any product claiming to contain retatrutide is unregulated and potentially dangerous.
FDA Recommendations: How to Stay Safe
To protect public health, the FDA recommends the following steps for patients seeking GLP-1 medications:
- Only obtain GLP-1 prescriptions from licensed healthcare providers and fill them at state-licensed pharmacies.
- Avoid purchasing medications online unless from a verified and licensed source.
- Consult a physician before considering any weight loss treatment, including compounded versions.
- Understand proper dosing and administration techniques to prevent health complications.
Alternative Safe and Effective Weight Loss Strategies
While GLP-1 drugs can aid in weight management, they should be used under medical supervision. Patients looking for safer alternatives may consider:
- Medically supervised weight loss programs with FDA-approved medications.
- Lifestyle modifications, including improved nutrition, increased physical activity, and behavioral counseling.
- Personalized metabolic health assessments to determine the best weight management approach for their individual needs.
Reporting Adverse Events and Counterfeit Medications
Patients and healthcare professionals should report any adverse effects or suspected counterfeit drugs to the FDA’s MedWatch program:
- Submit reports online through the FDA MedWatch website.
- Fax a completed form to 1-800-FDA-0178.
- Contact the FDA directly at druginfo@fda.hhs.gov or 855-543-3784.
Conclusion
The increasing availability of unapproved and compounded GLP-1 drugs poses a major risk to public health. At Sterling Medical Center, we advocate for patient safety by encouraging the use of FDA-approved treatments and discouraging the use of unregulated alternatives. By prioritizing well-researched, medically supervised weight loss solutions, patients can achieve their health goals without unnecessary risks.
Also Read: GLP-1 Supply Issues Easing