FDA warns on safety of SGLT2 inhibitor diabetes drugs

The US Food and Drug Administration is warning that several type 2 diabetes drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors, may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.

These drugs include AstraZeneca's (LSE: AZN) Farxiga (dapagliflozin), Johnson & Johnson’s (NYSE: JNJ) Invokana (canagliflozin) and Jardiance (empagliflozin) from Eli Lilly (NYSE: LLY) and Germany family-owned Boehringer Ingelheim. In a posting on its website on Friday, the FDA says it is continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs.

Meantime, the agency says patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels.