A Survey of the FDA's Adverse Event Reporting System Database Concerning Urogenital Tract Infections and Sodium Glucose Cotransporter-2 Inhibitor Use.

INTRODUCTION

We tested the possible association between sodium glucose cotransporter-2 inhibitor (SGLT-2i) use and urogenital tract infection (UTI) occurrences by assessing the publicly available US Food and Drug Administration Adverse Event Reporting System (FAERS).

METHODS

Disproportionality analysis and Bayesian analysis were used to mine FAERS for suspected UTI data for SGLT-2i use from the first quarter of 2004 to the second quarter of 2018.

RESULTS

On the basis of 37,100 reports, 1628 reports (4.39% of total adverse drug reactions, ADRs) were associated with UTIs; among them, the number of UTIs reported for the top four was as follows: canagliflozin, 858 (52.74%); dapagliflozin, 324 (19.91%); empagliflozin, 189 (11.62%); and empagliflozin/metformin, 183 (11.25%). Although the number of ADRs reported for these drugs is different, their risk of causing UTIs is determined. Of the reports of SGLT-2i adverse events related to UTIs, 61.73% occurred in women, which was a much higher proportion than that in men (28.50%).

CONCLUSION

FAERS data were consistent with clinical studies on a strong association between SGLT-2i use and UTIs. The results strongly suggest that female patients are more likely than male patients to experience UTIs when using SGLT-2i.