A safety review by the Food and Drug Administration (FDA) has resulted in label changes for a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors (canagliflozin, dapagliflozin, and empagliflozin). The warnings include the risks of too much acid in the blood and of serious urinary tract infections. Both conditions can result in hospitalization.
The new labels include prescribing and monitoring recommendations. Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis, which include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.
Healthcare 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.
More information on the MedWatch Safety Alert can be found on the FDA’s website.
Endocrine Society experts discussed the adverse events associated with SGLT-2 inhibitors at CEU 2015, and offered insights on how practices and patients might be affected.
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