FDA Issues Alert Cautioning Against the Use of Glucose Control Product Containing Metformin, Glyburide

The FDA has issued an alert regarding the purchase and use of products containing glyburide and metformin that are marketed for the management of blood glucose. In the warning, the FDA said that Dr. Ergin’s SugarMD Advanced Glucose Support should be avoided for its marketed use because glyburide and metformin are active ingredients in several prescription-only medications indicated for the treatment of patients with type 2 diabetes.

The product was being sold at www.sugarmds.com and potentially in some retail stores.

The non-prescribed and unregulated use of metformin may elevate the risk of lactic acidosis, which is a rare but potentially fatal adverse effect (AE) in which lactic acid accumulates in the blood. Consumers and care providers should be cognizant of symptoms such as nausea, vomiting, fatigue, body aches, respiratory distress, abdominal pain, and fast, deep breathing.

Both glyburide and metformin have also been linked to an increased risk of hypoglycemia in specific instances in which the product is taken with other treatments that seek to lower blood sugar.

The FDA warns that instances of hypoglycemia can rapidly become severe, and may lead to seizures, coma, or death. The FDA urged consumers and clinicians to be aware of symptoms such as fast heartbeat, shaking, sweating, anxiety, irritability or confusion, dizziness, drowsiness, headache, and hunger.

The FDA warning urged patients to inform their health care providers of all current prescription and non-prescription medications they are currently taking to help interpret the risk of these AEs.

“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 FDA said in the statement. “The risks associated with both glyburide and metformin are greatest in people with chronic kidney disease.”

The FDA added that consumers should properly dispose the blood glucose management product and report any AEs or other effects related to the product to the FDA.

Reference

FDA. FDA warns consumers of hidden drug ingredients in Dr. Ergin’s SugarMD Advanced Glucose Support. Press release. Last updated November 3, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-hidden-drug-ingredients-dr-ergins-sugarmd-advanced-glucose-support?utm_medium=email&utm_source=govdelivery