WASHINGTON — The FDA made changes to the safety labeling information for sodium glucose co-transporter-2 (SGLT2) inhibitors to recommend the T2D drugs be discontinued prior to surgery.
SGLT2 inhibitors, particularly dapagliflozin, made waves in the last months of 2019 after investigators from the DAPA-HF trial found that the drug reduced premature death and hospitalizations in patients both with and without T2D. But now, the FDA is warning that taking dapagliflozin, canagliflozin, empagliflozin, or ertugliflozin in the days leading to scheduled surgery can put patients at greater risk for developing ketoacidosis.
Due to this increased risk, the FDA has approved the following changes to the safety labeling for these drugs:
- "Canagliflozin, dapagliflozin, 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 agency added that patients can begin taking their SGLT2 inhibitors again once their oral intake is back to baseline and any other risk factors for ketoacidosis, such as blood acid build-up, have resolved.
In its drug information update, the FDA reiterated additional side-effects that patients can develop while taking SGLT2 inhibitors, including 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," the agency warned. "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 patients also taking insulin or insulin-secreting agents. 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."