FDA issues safety alert about SGLT2 inhibitors and potential link with ketoacidosis

The FDA has issued a warning that the SGLT2 inhibitors (canagliflozin, dapagliflozin, and empagliflozin) may lead to ketoacidosis. Healthcare professionals are advised to discontinue SGLT2 inhibitors, correct acidosis and monitor glucose levels if acidosis is confirmed.

The warning is based on a search of the FDA Adverse Event Reporting System database which identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 2014.  All patients required emergency treatment or hospitalisations to treat the ketoacidosis.

 

Further reports for DKA and ketoacidosis have been received since June 2014, in patients treated with SGLT2 inhibitors; therefore the FDA will continue to investigate this safety issue.

 

This is FDA advice and there is currently no related MHRA guidance available to assess implications for practice in the UK.