Unregulated Weight Loss Drugs Raise Safety Concerns: ADA Issues Warning
The American Diabetes Association (ADA) has issued a warning against the use of compounded medications designed to mimic popular GLP-1 receptor agonist (GLP-1 RA) and dual GIP/GLP-1 RA drugs. These medications, while often marketed as solutions for weight loss, are not FDA-approved and carry significant potential risks.
The ADA strongly advises patients to stick to GLP-1 RA and GIP/GLP-1 RA medications that have received FDA approval. These medications have undergone rigorous testing and are proven effective in managing type 2 diabetes, reducing the risk of cardiovascular and kidney disease, and promoting weight loss.
The concern surrounding compounded versions stems from several factors. "Compounded GLP-1 RA and dual GIP/GLP-1 RA products have been associated with clinically important dosing errors and adverse events," the ADA stated. In a statement published on December 2, 2024, in Diabetes Care, the ADA expressed its deeper fear: "More concerning to individuals’ safety are counterfeit products that have made their way into the US drug supply chain and those advertised online and by unregulated sources."
This warning comes at a time when demand for weight loss medications has surged, leading to both shortages of FDA-approved drugs and the emergence of unregulated alternatives.
The ADA acknowledges that financial constraints or medication shortages may lead individuals and healthcare providers to consider compounding pharmacies. However, they strongly caution against this practice, stating: "Non-FDA–approved compounded incretin products are not recommended for use due to uncertainty about their content and resulting concerns about safety, quality, and effectiveness."
For those struggling to access FDA-approved medications, the ADA suggests exploring alternatives.
“If an incretin medication is unavailable (eg, in shortage), switching to a different FDA-approved medication is recommended as clinically appropriate to achieve and maintain individualized glucose-lowering, weight management, and/or cardiovascular and kidney risk reduction goals."
Once FDA-approved medications become available again, the ADA advises reassessing the patient’s individual needs to determine the best course of treatment.
The ADA also offers guidance for individuals who still choose to pursue compounded medications:
- Consult your healthcare provider. Open communication is crucial to making informed decisions about your treatment.
- Demand dosing guidance. Ensure the compounded product comes with clear instructions for use.
- Verify the compounding pharmacy’s registration with the FDA. This step offers a level of assurance regarding adherence to quality standards.
- Report any adverse events or medication errors to the FDA’s Medwatch program. This helps track potential safety issues and protect other patients.
The ADA’s warning serves as a timely reminder that when it comes to health, taking shortcuts can have dangerous consequences. By choosing FDA-approved medications and working closely with healthcare providers, patients can make safe and informed decisions about their weight management and overall well-being.
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape Medical News, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X @MiriamETucker.
Link to the original Diabetes Care statement
Link to the FDA’s Medwatch program
