ADA Issues Warning About Compounded Weight-Loss Medications
The American Diabetes Association (ADA) has issued a strong warning against using compounded versions of medications intended for type 2 diabetes, specifically glucagon-like peptide 1 receptor agonist (GLP-1 RA) and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA medications, often marketed for weight loss.
Concerns Over Safety and Unregulated Production
The ADA emphasizes the importance of sticking with FDA-approved GLP-1 RA and GIP/GLP-1 RA medications for treating type 2 diabetes, cardiovascular disease, kidney health, and weight management. The statement specifically targets the growing availability of unapproved, unregulated compounded versions of these medications that have emerged due to increasing demand for weight loss solutions.
“Compounded GLP-1 RA and dual GIP/GLP-1 RA products have been associated with clinically important dosing errors and adverse events. 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,” the ADA stated in the December 2, 2024, issue of Diabetes Care.
Potential Risks and Lack of Standardization
The ADA highlights several concerns regarding the use of compounded versions of these medications. Primarily, they stress the lack of standardization in these products. Compounded medications are not identical to FDA-approved versions, potentially leading to dosage inconsistencies and unexpected side effects. Furthermore, they may be distributed in nonstandard dosing devices and lack sufficient user instructions, increasing the risk of medication errors.
The statement, authored by Joshua J. Neumiller, PharmD, CDCES, of the Department of Pharmacotherapy, Washington State University, Spokane, Washington, and colleagues, outlines specific recommendations for individuals and clinicians.
Key ADA Recommendations
* **FDA-Approved Medications:**
The ADA strongly recommends using FDA-approved GLP-1 RA and GIP/GLP-1 RA medications for safe and effective treatment.
* **Alternative Medications in Case of Shortages:**
If an FDA-approved incretin medication is temporarily unavailable, the ADA suggests switching to a different FDA-approved medication that can effectively achieve and maintain individualized health goals related to glucose control, weight management, and cardiovascular/kidney risk reduction.
* **Resuming Original Medication:**
Upon resolution of any incretin medication shortages, the ADA advises reassessment of the appropriateness of resuming the original FDA-approved medication.
Cautions and Advice for Consumers
Recognizing that some individuals may still opt to use compounded products for financial reasons or limited accessibility, the ADA offers essential advice for those considering these options:
* **Consult Your Healthcare Provider:**
It is crucial to discuss the use of compounded medications with a healthcare provider to understand the potential risks and benefits.
* **Scrutinize Product Information:**
Only use compounded products that come with clear and comprehensive dosing guidance.
* **Verify Pharmacy Registration:**
Ensure that the compounding pharmacy is registered with the FDA, indicating adherence to certain quality and safety standards.
* **Report Adverse Events:**
The ADA urges individuals to report any adverse events or medication errors related to compounded products to the FDA’s MedWatch program.
What are the risks associated with using compounded weight-loss medications?
## Weight-Loss Meds: The Risks of Going Unregulated
**Host:** Welcome back to Healthline Headlines. Today, we’re discussing a recent warning issued by the American Diabetes Association (ADA) concerning compounded weight-loss medications. Joining us to unpack this is Dr. Emily Carter, a leading endocrinologist. Dr. Carter, thank you for being here.
**Dr. Carter:** It’s my pleasure to be here.
**Host:** For our viewers who may be unfamiliar, can you explain what compounded medications are and why the ADA is cautioning against their use, particularly for weight loss?
**Dr. Carter:** Absolutely. Compounded medications are essentially made at a local pharmacy, tailor-made to a specific prescription. While this can be helpful in certain situations, it raises red flags when it comes to medications like GLP-1s, which are often prescribed for both type 2 diabetes and weight management.
The ADA is warning against them because they’re not FDA-approved, meaning they haven’t undergone the rigorous safety and efficacy checks that FDA-approved drugs go through [[1](https://www.beckershospitalreview.com/pharmacy/diabetes-group-recommends-against-compounded-glp-1s.html)]. This lack of standardization means the dosage can vary widely, potentially leading to unexpected side effects or dosing errors.
**Host:** So, essentially, there’s no guarantee you’re getting the same medication as someone else taking the same compounded version?
**Dr. Carter:** Exactly. Additionally, there’s a risk of counterfeit products infiltrating the market, which could be extremely dangerous.
**Host:** What advice would you give to someone considering these compounded weight-loss medications?
**Dr. Carter:** My advice is clear – stick with FDA-approved medications under the care of a healthcare professional. There are safe and effective weight-loss options available that have been thoroughly vetted.
**Host:** Dr. Carter, thank you for shedding light on this important issue.
**Dr. Carter:** My pleasure. It’s crucial for everyone to be informed and make safe decisions about their health.
