American Diabetes Association Releases Statement on GLP 1 Agonist Shortages

The American Diabetes Association has issued a statement in light of shortages of GLP 1 and dual GIP/GLP 1 receptor agonists, like Ozempic.

Specifically, the statement stresses that “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.” However, if an incretin medication is unavailable, “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.”

The Federal Food, Drug, and Cosmetic (FD&C) Act “allows for compounding of GLP-1 RA and dual GIP/GLP-1 RA therapies by licensed and approved facilities while under shortage (and, specifically, listed on the FDA drug shortage list),” but some concerns still remain. For one, these compounded therapies “are not identical to the FDA-approved products. Alarmingly, compounded products “have been associated with clinically important dosing errors and adverse events.” Yet more concerningly, counterfeit products have made their way into the market.

Individuals who elect to use a compounded product are encouraged to “discuss use of the compounded product with their usual healthcare professional,” “seek and receive guidance about appropriate dosing and administration from the compounding pharmacy,” “verify the compounding pharmacy is registered with the FDA,” “avoid purchasing compounded products online,” and “notify their usual care team when they start or stop a compounded product.”