FDA warning of possible ketoacidosis associated with SGLT2 inhibitor treatment of type 2 diabetes.

The FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. FDA is continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors.The FDA concerns followed a search of the FDA Adverse Reporting System.

Comment: The FDA recommends that health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing signs or symptoms of ketoacidosis, such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness and discontinue SGLT2 inhibitors if acidosis is confirmed.