WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently approved label changes for SGLT2 inhibitors. The FDA said that it recommends doctors advise patients to discontinue SGLT2 medications before surgery to reduce the possible risk for diabetic ketoacidosis. Healio.com reported that SGLT2 drug Invokana (canagliflozin) made Janssen, Farxiga (dapagliflozin) produced by AstraZeneca, and Jardiance (empagliflozin) manufacturer by the joint venture of Eli Lilly and Boehringer Ingelheim, and Steglatro (ertugliflozin) produced by Merck must all be stopped within three to four days before any surgical procedure. The FDA recommended that the patients’ blood glucose levels must be monitored very closely after stopping the medication before surgery. Changing the label puts patients and doctors on notice of the possible side effects and contraindications of the medication.
These medications are typically prescribed for people battling type-2 diabetes and can sometimes be prescribed to people with type-1 diabetes as an “off-label” treatment. The FDA expressed reluctance in approving these medicines for type-1 diabetics because of the heightened risk of ketoacidosis. These medications are instrumental in maintaining healthy blood sugar levels in diabetic patients and can be restarted when the patient’s food intake is back to normal after surgery, and the other attendant risk factors for ketoacidosis have faded.
The FDA published the label change on diabetic drugs because of the heightened risk of ketoacidosis. Diabetic ketoacidosis manifests in various ways such as vomiting, nausea, stomach pain, difficulty breathing, and extreme fatigue. Ketoacidosis could be fatal in some cases.
SGLT2 inhibitors have a long list of possible deadly side effects. Some of the known side effects include hypotension, acute kidney damage, necrotizing fasciitis or the perineum, ketoacidosis, along with hypersensitivity. Specifically, canagliflozin can lead to lower limb amputation. Kidney damage is a known side effect of empagliflozin as well as ertugliflozin. SGLT2 inhibitors are not appropriate for people who need dialysis, renal impairment, or have end-stage renal disease.
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