FDA approves label update to sodium glucose co-transporter-2 (SGLT2) inhibitors

Safety updates to labels of SGLT2 inhibitors will recommend temporary discontinuation of these medications before scheduled surgery, says the FDA.

Woman holding pill bottle

The US Food and Drug Administration (FDA) has approved safety labelling changes to a class of type 2 diabetes medications called sodium glucose co-transporter-2 (SGLT2) inhibitors, which includes canagliflozin, dapagliflozin, empagliflozin and ertugliflozin. According to the regulatory body, 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, says the FDA, while ertugliflozin should be discontinued at least four days before scheduled 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. 

The FDA says that it 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 with 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, the FDA says. 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 (fungal) infections. Acute kidney injury, hypotension (low blood pressure), necrotising fasciitis of the perineum and hypersensitivity have also occurred among people taking SGLT2 inhibitors. Canagliflozin is associated with an increased risk of lower limb amputation, while impairment in renal function is also a side effect of empagliflozin and ertugliflozin.