FDA Approves SGLT2 Inhibitor Safety Labeling Changes

The US Food and Drug Administration (FDA) has approved safety labeling changes to the packaging of sodium-glucose co-transporter-2 (SGLT2) inhibitors, now advising temporary cessation of SGLT2 inhibitors among patients with type 2 diabetes who are scheduled to undergo a surgical procedure.

According to the FDA, the new safety labeling changes are geared towards lowering the risk of ketoacidosis associated with surgery in this patient population.

The new safety labeling changes include:

  • Treatment with canagliflozin, dapagliflozin, and empagliflozin should each be discontinued 3 days or more prior to a scheduled surgical procedure.
  • Treatment with hertugliflozin should be discontinued 4 or more days prior to a scheduled surgical procedure.
  • Blood glucose levels should be monitored vigilantly after temporary cessation of SGLT2 inhibitor treatment and managed appropriately prior to a surgical procedure.

—Christina Vogt

FDA approves label changes to SGLT2 inhibitors regarding temporary discontinuation of medication before scheduled surgery. News release. US Food and Drug Administration. Accessed March 19, 2020.