FDA Revises Labels of SGLT2 Inhibitors

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FDA large logoA U.S. FDA safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors (such as Invokana, Farxiga and Jardiance) about the risks of too much acid in the blood and of serious urinary tract infections.  Both conditions can result in hospitalization.

Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of 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.  Patients should also be alert for signs and symptoms of a urinary tract infection, such as a feeling of burning when urinating or the need to urinate often or right away; pain in the lower part of the stomach area or pelvis; fever; or blood in the urine.  Contact a health care professional if you experience any of these symptoms.

Health care professionals should assess for ketoacidosis and urinary tract infections in patients taking SGLT2 inhibitors who present with suggestive symptoms.  Ketoacidosis associated with the use of SGLT2 inhibitors can occur even if the blood sugar level is not very high.  If ketoacidosis is suspected, the SGLT2 inhibitor should be discontinued and treatment instituted promptly.

SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.  When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.  Medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, and empagliflozin (see section on List of FDA-approved SGLT2 Inhibitors for Type 2 Diabetes).  SGLT2 inhibitors are not FDA-approved for use in patients with type 1 diabetes.

The FDA issued a Drug Safety Communication in May 2015 warning about the risk of ketoacidosis with SGLT2 inhibitors and alerting that they would continue to evaluate this safety issue.

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