FDA Approves Label Changes to SGLT2 Inhibitors - Drug Information Update

FDA Approves Label Changes to SGLT2 Inhibitors Regarding Temporary Discontinuation of Medication Before Scheduled Surgery

The U.S. Food and Drug Administration has approved safety labeling changes to a specific class of type 2 diabetes medications called sodium glucose co-transporter-2 (SGLT2) inhibitors, which includes canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. These changes recommend temporary discontinuation of these medications before scheduled surgery. Canagliflozin, dapagliflozin, and empagliflozin should each be discontinued at least three days before scheduled surgery. Ertugliflozin should be discontinued at least four days before scheduled surgery. Blood glucose levels should be carefully monitored after discontinuation of the SGLT2 inhibitor and appropriately managed before surgery. The SGLT2 inhibitor may be re-started once the patient’s oral intake is back to baseline and any other risk factors for ketoacidosis (blood acid buildup) are resolved. FDA approved the label change because surgery may put patients at greater risk for developing ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. Their safety and effectiveness have not been established to treat diabetic ketoacidosis or to treat patients with type 1 diabetes. These medications are available as single-ingredient therapies and also in combination with other diabetes medicines. While side effects vary among SGLT2 inhibitors, they can include urinary tract infections and genital mycotic (fungus) infections. Acute kidney injury, hypotension (low blood pressure), ketoacidosis, necrotizing fasciitis of the perineum (a type of severe bacterial infection), and hypersensitivity have also occurred among people taking SGLT2 inhibitors. Canagliflozin is associated with an increased risk of lower limb amputation. Impairment in renal (kidney) function is also a side effect of empagliflozin and ertugliflozin. Hypoglycemia (low blood sugar) can occur in patients also taking insulin or insulin-secreting agents. Patients with severe renal impairment, end-stage renal disease, who are on dialysis treatment, or with a known hypersensitivity to the medication should not take SGLT2 inhibitors.