FDA Warns About Over-the-Counter Glucose-Lowering Product

Miriam E. Tucker

November 07, 2023

The US Food and Drug Administration (FDA) has warned against the use of an over-the-counter product called “Dr. Ergin’s SugarMD Advanced Glucose Support” because it was found to contain the prescription glucose-lowering medications metformin and glyburide.

The product was sold on the website www.sugarmds.com and was promoted for blood glucose management. It is no longer available at that site but may still be sold elsewhere.

“If consumers and their health care providers are unaware that glyburide or metformin are present in a product, they may end up taking a larger combined dose of the diabetic drugs than they intended, which can cause hypoglycemia or lactic acidosis. The risks associated with both glyburide and metformin are greatest in people with chronic kidney disease,” the FDA warned in a statement.

The agency is unaware of any adverse events related to use of the product but recommends that consumers discard any they may have.

Reached for comment, SugarMD managing director and chief executive officer Ahmet Ergin, MD, told Medscape Medical News that the FDA warning “has caused great concern for us as SugarMD brand as well as among our customers,” and also that the product was actually discontinued months ago for unrelated reasons.

However, he added, “the FDA has refused to provide us with the test results or answer our questions regarding their testing methodology. Instead, they have released a letter making it seem as though all SugarMD products are contaminated without any solid evidence presented. At SugarMD, we take the safety and well-being of our customers very seriously. It is important to note that we have not received any negative feedback about the product.”

Ergin, an endocrinologist in Port St. Lucie, Florida, also said that his company “will continue to work closely with the FDA to address their concerns and ensure that our products meet the highest standards of quality and safety” and “will provide updates on this matter as they become available.”

In the meantime, the FDA advises healthcare professionals and consumer to report any adverse events or side effects related to the use of the product to the FDA’s MedWatch safety information and adverse event reporting program.

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diabetes Forecast magazine. She is on X @MiriamETucker.