A Description of Acute Renal Failure and Nephrolithiasis Associated With Sodium-Glucose Co-Transporter 2 Inhibitor Use: A VigiBase Study.

ABSTRACT: Background: The Food and Drug Administration issued a warning on the risk of acute kidney injury and a signal of nephrolithiasis for patients using sodium-glucose co-transporter 2 inhibitors (SGLT2i). We performed a descriptive analysis on acute renal failure (ARF) and nephrolithiasis cases reported to SGLT2i in the VigiBase^®, in the scope of characterizing the patients and reactions and to report on the disproportionality analysis. Methods: We analyzed all ARF and nephrolithiasis reports for SGLT2i in VigiBase from inception to September 2021. ARF cases were defined as reports containing at least one of the preferred terms (PTs) included in the ARF narrow Medical Dictionary for Regulatory Activities Standardised Queries (MedDRA SMQ). SGLT2i exposure was considered

SUBMITTER: Frent I 

PROVIDER: S-EPMC9393368 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature