March 17, 2020
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FDA: Suspend SGLT2 inhibitors before surgery

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The FDA on Tuesday approved safety labeling changes for all SGLT2 inhibitors, recommending temporary discontinuation of the medications before any scheduled surgery to avoid potential risk for diabetic ketoacidosis, according to an agency press release.

The drugs canagliflozin (Invokana, Janssen), dapagliflozin (Farxiga, AstraZeneca) and empagliflozin (Jardiance, Boehringer Ingelheim, Eli Lilly) should each be discontinued at least 3 days before a scheduled surgery; ertugliflozin (Steglatro, Merck) should be discontinued at least 4 days before a scheduled surgery, according to the FDA. The agency cautioned that blood glucose levels should be carefully monitored after discontinuation and appropriately managed before surgery. The class of medications is commonly prescribed for people with type 2 diabetes and sometimes prescribed off-label for people with type 1 diabetes.

“The SGLT2 inhibitor may be re-started once the patient’s oral intake is back to baseline and any other risk factors for ketoacidosis are resolved,” the agency stated in the release.

The FDA approved the label change because surgery may put patients at greater risk for developing diabetic ketoacidosis (DKA). Symptoms of DKA include nausea, vomiting, abdominal pain, tiredness and trouble breathing. The FDA has been hesitant to approve SGLT2 inhibitors for use in people with type 1 diabetes, citing concern about a potential risk for DKA.

While side effects vary among SGLT2 inhibitors, they can include urinary tract infections and genital mycotic infections. Acute kidney injury, hypotension, ketoacidosis, necrotizing 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. Impairment in renal function is also a side effect of empagliflozin and ertugliflozin. Hypoglycemia can occur in people also taking insulin or insulin-secreting agents. SGLT2 inhibitors are not indicated for people on dialysis or those with severe renal impairment, end-stage renal disease or a known hypersensitivity to the medication. – by Regina Schaffer