Washington DC – The US Food and Drug Administration (FDA) issued a warning against the purchase and use of blood glucose management product that contain glyburide and metformin according to laboratory tests.
According to an FDA statement last week, Dr. Ergin’s SugarMD Advanced Glucose Support should be avoided for its marketed use due to the presence of glyburide and metformin—both of which are active ingredients in a number of prescription-only medications approved by the FDA to treat patients with type 2 diabetes (T2D).
Non-prescribed and unregulated use of metformin may put consumers at risk of lactic acidosis, a rare but serious, and potentially fatal, adverse effect wherein lactic acid accumulates in the blood. Consumers and their physicians should be aware of symptoms included nausea; vomiting; fatigue; body aches; respiratory distress; abdominal pain; and fast, deep breathing.
Metformin and glyburide are additionally associated with increased risk of hypoglycemia—the former in specific instances when it is taken in combination with other blood sugar-targeting therapies. The FDA warned that cases of hypoglycemia may become severe quickly, and may result in seizures, coma or death. Consumers and physicians should be aware of symptoms including fast heartbeat; shaking; sweating; anxiety; irritability or confusion; dizziness; drowsiness; headache and hunger.
The FDA’s statement regarding the glucose support product warning emphasized that patients should inform their health care providers of all their current prescription and non-prescription medications to help interpret risk of these adverse effects.
“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 statement read. “The risks associated with both glyburide and metformin are greatest in people with chronic kidney disease.”
The FDA further recommended that consumers properly discard the blood glucose management product, and together with their health care provider report any adverse events or effects related to the product through the agency.
Contact
Jeremy Kahn
US Food and Drug Administration (FDA)
1-888-463-6332