SGLT2 Inhibitors and Diabetic Ketoacidosis: Data From the FDA Adverse Event Reporting System

Regulatory agencies have reported a potential link between sodium-glucose cotransporter-2 (SGLT-2) inhibitor use and diabetic ketoacidosis (DKA). To examine this, investigators conducted a detailed analysis of DKA events observed in patients using SGLT-2 inhibitors, as reported to the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). FAERS data covered the first quarter of 2014 through the third quarter of 2016; data were evaluated using proportional reporting ratios (PRRs) and safety signals. The FAERS database contained >2,500 DKA reports in which SGLT-2 inhibitors were listed as concomitant drugs; the overall PRR of DKA for patients with diabetes receiving an SGLT-2 inhibitor vs no SGLT-2 inhibitor was 7.9 (95% CI 7.5, 8.4). This ratio was substantially higher (57.3) for patients with type 1 diabetes. A detailed analysis of DKA/SGLT-2 inhibitor reports indicated a predominance of women (female:male ratio 1.21), an extremely wide range of patient ages (14-90 years) and body weight, and a highly variable duration of SGLT-2 inhibitor use prior to DKA onset. Follow this link to read the study abstract.