On May 15, 2015, the United States Food and Drug Administration (FDA) issued a warning that SGLT2 inhibitors including Invokana (canagliflozin), Farxiga (dapagliflozin) and Jardiance (empagliflozin) may cause ketoacidosis leading to prolonged hospitalization and possibly death. Ketoacidosis is a serious metabolic state where ketones accumulate in the blood in such high concentrations that the pH of the blood is substantially and dangerously decreased.
SGLT2 inhibitors are a new group of oral medications approved by the FDA in 2013 for the treatment of Type 2 diabetes. These medications work by preventing the kidneys from reabsorbing glucose back into the blood. This allows the kidneys to lower blood glucose levels and the excess glucose in the blood is removed from the body via urine.
Importantly, the prescribing information for SGLT2 inhibitors has failed to warn physicians and patients about the risk of ketoacidosis.
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