SGLT2 Inhibitor Safety Label Changes

FDA has approved safety labeling changes to sodium glucose co-transporter-2 (SGLT2) inhibitors indicated to treat Type 2 diabetes. The changes recommend temporary discontinuation of the medications before a scheduled surgery. An agency online notice says that Janssen’s Invokana (canagliflozin), AstraZeneca’s Farixga (dapagliflozin), and Boehringer Ingelheim/Lilly’s Jardiance (empagliflozin) should be discontinued at least three days before a scheduled surgery, while Merck’s Steglatro (ertugliflozin) should be discontinued at least four days before a scheduled surgery.

Blood glucose levels should be carefully monitored after discontinuation of the SGLT2 inhibitor and appropriately managed before surgery, FDA says. The notice says the label changes were approved because surgery may put patients at greater risk for developing ketoacidosis with symptoms that could include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.