Urinary tract infections and genital mycotic infections associated with SGLT‑2 inhibitors: an analysis of the FDA Adverse Event Reporting System

Ting Yang; Ying Zhou; Yimin Cui

doi:10.1080/14740338.2023.2288897

Urinary tract infections and genital mycotic infections associated with SGLT‑2 inhibitors: an analysis of the FDA Adverse Event Reporting System

Expert Opin Drug Saf. 2023 Nov 27:1-6. doi: 10.1080/14740338.2023.2288897. Online ahead of print.

Authors

Ting Yang¹, Ying Zhou¹, Yimin Cui^{1

2}

Affiliations

¹ Department of Pharmacy, Peking University First Hospital, Beijing, China.
² Institute of Clinical Pharmacology, Peking University, Beijing, China.

PMID: 38009230
DOI: 10.1080/14740338.2023.2288897

Abstract

Background: Sodium-glucose cotransporter-2 (SGLT-2) inhibitors are a class of antihyperglycemic agents, including canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. Risk of urinary tract infections (UTIs) and genital mycotic infections (GMIs) associated with SGLT‑2 inhibitors is of great clinical significance. The study aimed to assess the association between SGLT-2 inhibitors and occurrences of UTIs and GMIs using the FDA Adverse Event Reporting System (FAERS) database.

Methods: We used OpenVigil 2.1-MedDRA-v24 to query the FAERS database. Disproportionality analysis was performed to detect adverse event signals. Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) were calculated to measure the disproportionality.

Results: A total of 45,256 reports related to the use of SGLT-2 inhibitors, including 1,714 UTI cases and 438 GMI cases, were retrieved. Potential positive signals for UTIs and GMIs were identified for canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin in adult patients of all ages and both sexes.

Conclusions: Data mining in the FAERS database suggests strong association between SGLT-2 inhibitors and UTIs/GMIs. These findings provide real-world evidence on the potential risk of UTIs/GMIs related to SGLT-2 inhibitors.

Keywords: Adverse event reporting system; SGLT-2 inhibitors; disproportionality analysis; genital mycotic infections; urinary tract infections.