FDA Approves Safety Labeling Changes to SGLT2 Inhibitors

Officials with the FDA have approved safety labeling changes to sodium glucose co-transporter-2 (SGLT2) inhibitors, which are used to treat high blood sugar in patients with type 2 diabetes, according to a press release.

The changes recommend temporary discontinuation of SGLT2 inhibitors before scheduled surgery due to the greater risk of patients developing ketoacidosis.

According to the updated label:

• Canagliflozin, dapagliflozin, and empagliflozin should each be discontinued at least 3 days before scheduled surgery.

• Ertugliflozin should be discontinued at least 4 days before scheduled surgery.

• Blood glucose levels should be carefully monitored after discontinuation of the SGLT2 inhibitor and appropriately managed before surgery.

The FDA indicated that SGLT2 inhibitor therapy may restarted once the patient’s oral intake is back to baseline and any other risk factors for ketoacidosis are resolved.

SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine, but has not be established for use to treat diabetic ketoacidosis or type 1 diabetes. Adverse effects associated with use of these medications can include urinary tract infections and genital mycotic infections. Additionally, 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, according to the FDA.

References:

1. FDA Approves Label Changes to SGLT2 Inhibitors Regarding Temporary Discontinuation of Medication Before Scheduled Surgery [news release]. FDA’s website. http://s2027422842.t.en25.com/e/es?s=2027422842&e=312220&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=88805802632f4dc88dd18426307959d3&elqaid=11643&elqat=1. Accessed March 23, 2020.