Leading Obesity Expert Organizations Release Statement to Patients on Compounded GLP-1 Alternatives

This year, many people will begin the journey of eagerly pursuing health goals, especially in terms of body weight. Throughout the years, weight has proven challenging for many, with long-term success elusive. Today, there's renewed optimism due to the emergence of GLP1-based drug therapies like Wegovy (semaglutide) and Zepbound (tirzepatide), which demonstrate remarkable effectiveness for weight and health.

However, many have experienced frustration when trying to access one of the FDA-approved treatments. Access may be limited because of medication shortages, lack of insurance coverage, and high out-of-pocket costs. When you’ve made up your mind to lose weight, meeting this kind of barrier to getting started only worsens your sense of frustration and can drive you to look for any available alternative.

Unfortunately, many of the available alternatives, like compounded versions of semaglutide and tirzepatide, are not what they are advertised to be. These compounded versions are not the same as the drug provided by the manufacturers. The FDA stated very clearly that, “Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations.” Why does this matter? Simply put, the salt formulations of these drugs have not been shown to be safe and effective and are not FDA-approved.

To be clear, the only FDA-approved manufacturers of these medications are the companies that created the active pharmaceutical ingredients—Novo Nordisk and Eli Lilly. These companies stated that they do not sell the active ingredient to compounding pharmacies, and substances made or distributed by compounding pharmacies or other healthcare practitioners that claim to be semaglutide (Wegovy, Ozempic) or tirzepatide (Zepbound, Mounjaro) have not been reviewed by the FDA for safety, quality, or efficacy. Worse yet, there are reports that these counterfeits may pose serious health risks because of impurities or other non-pharmaceutical additives due to lack of regulatory oversight.

Therefore, we do not recommend the use of these alternatives. If you use these compounded alternatives, you may not be getting what you hoped for. You may also get something you did not want (other active substances have been found in some compounded versions). And, if there is a health concern that arises from the use of the alternative compound, pinpointing the cause could be difficult.

Obesity is a serious disease; FDA-approved treatment that is effective and safe is available. Even if you cannot find or get access to a GLP1-based treatment now, there are other treatments available. Please use the same care when trying to treat obesity as you would any other serious medical condition.

For more information, see the following details:

Compounded peptides: An Obesity Medicine Association Position Statement - ScienceDirect | Obesity Medicine Association

Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss | FDA

Compounding and the FDA: Questions and Answers | FDA

Open Letter Regarding the Use of Mounjaro® (tirzepatide) and Zepbound™ (tirzepatide) | Eli Lilly and Company

Responsible Use Letter | Novo Nordisk

Things You Should Know About Compounded Anti-Obesity (AOM) Medications | Obesity Medicine Association