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 canagliflozindapagliflozinempagliflozin, and ertugliflozin.

These changes recommend temporary discontinuation of these medications before scheduled surgery.

·         Canagliflozindapagliflozin, 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.

From www.medscape.com


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