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Obesity expert groups take stance against compounded GLP-1 agonists

January 17, 2024

Despite the promise that obesity medications such as semaglutide (Wegovy) and tirzepatide (Zepbound) hold for remarkable effectiveness, frustrations exist regarding access to such FDA-approved treatments due to medication shortages, lack of insurance coverage, and high out-of-pocket costs. In a joint statement, dated January 9, three leading obesity expert groups warn against the use of compounded GLP-1 receptor agonists, some of which the FDA previously warned could be sold as the salt formulations. The salt formulations of these drugs, say the groups, have not been shown to be safe and effective and are not FDA-approved.

The statement goes on to say that the only FDA-approved manufacturers of these medications are Novo Nordisk and Eli Lilly, the companies that created the active ingredients. These companies have said that they don’t sell the active ingredients to compounding pharmacies and substances made/distributed by compounding pharmacies or other practitioners that claim to be semaglutide or tirzepatide haven’t been reviewed by the FDA for efficacy, safety, or quality. Moreover, potential exists for serious health risks associated with the use of such products, due to impurities or other non-drug additives that aren’t subject to regulatory oversight.

The expert groups, therefore, do not recommend the use of these alternatives. They urge patients to use the same care when trying to treat obesity as they would any other serious medical condition.

Source:

The Obesity Society; Obesity Action Coalition; Obesity Medicine Association. (2024, January 9). Leading Obesity Expert Organizations Release Statement to Patients on CompoundedGLP-1 Alternatives. [Joint Statement]. https://www.obesityaction.org/wp-content/uploads/GLP-1-Compounded-Alternative-Statement_Final_Logos-1.pdf