FDA warns of serious risks associated with SGLT2 inhibitors

FDA recently issued a drug safety communication that the labels of sodium-glucose cotransporter-2 (SGLT2) inhibitors include the risks of ketoacidosis and serious urinary tract infections, which can lead to hospitalization.

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In May 2015, the Agency had warned about the risk of ketoacidosis following a review of the FDA Adverse Event Reporting System (FAERS) database over a two-year period. Seventy-three cases of ketoacidosis had been identified in patients with type 1 and type 2 diabetes who were being treated with SGLT2 inhibitors.

In addition, following a review of the FAERS database from March 2013 to October 2014, 19 cases of urosepsis and pyelonephritis were identified with the use of SGLT2 inhibitors. All of these patients were hospitalized and some had to be admitted to the ICU or required dialysis to treat the kidney infection, FDA reported.

These safety issues have been added to all SGLT2 inhibitors as well as recommendations for prescribing and monitoring patients who are taking SGLT2 inhibitors. The manufacturers of this class of type 2 diabetes therapies must conduct a 5-year postmarketing study to analyze reports of ketoacidosis in patients treated with SGLT2 inhibitors.

Patients taking SGLT2 inhibitors who exhibit symptoms of ketoacidosis, such as nausea, vomiting, abdominal pain, tiredness, and difficulty breathing, should stop taking the SGLT2 inhibitors and be assessed by a healthcare professional immediately.

Any adverse events related to SGLT2 inhibitors should be reported to FDA's MedWatch Safety Information and Adverse Event Reporting Program by completing an online report.