FDA Approves Safety Changes in Labeling of SGLT2 Inhibitors

The Food and Drug Administration has approved safety changes in labeling of all sodium-glucose transporter 2 (SGLT2) inhibitors.

The new changes in labeling are that SGLT2 inhibitors, namely Canagliflozin, dapagliflozin, and empagliflozin, should be discontinued 3 days before scheduled surgery, and ertugliflozin should be stopped at least 4 days before the surgery. Blood sugar should be monitored after drug discontinuation and appropriately managed before surgery.

These changes have been made because surgery may put patients being treated with SGLT2 inhibitors at a higher risk of ketoacidosis.

"The SGLT2 inhibitor may be restarted once the patient's oral intake is back to baseline and any other risk factors for ketoacidosis are resolved," the agency added.

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
• Genital mycotic (fungus) infections
• Acute kidney injury
• Hypotension (low blood pressure)
• Ketoacidosis
• Necrotizing fasciitis of the perineum (a type of severe bacterial infection)
• Hypersensitivity

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.

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