Signal Detection of Adverse Drug Reactions of Cephalosporins Using Data from a National Pharmacovigilance Database.

ABSTRACT: This case-non-case study aims to detect signals not currently listed on cephalosporin drug labels. From 2009 to 2018, adverse event (AE) reports concerning antibacterial drugs (anatomical therapeutic chemical (ATC) code J01) in the Korea Adverse Events Reporting System (KAERS) database were examined. For signal detection, three indices of disproportionality, proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC), were calculated. The list of signals was compared with ADRs on the drug labels from the United States, United Kingdom, Japan, and South Korea. A total of 163,800 cephalosporin-AE combinations and 72,265 all other J01-AE combinations were analyzed. This study detected 472 signals and 114 new signals that are not included on the drug labels. C

SUBMITTER: Choi JY 

PROVIDER: S-EPMC8147424 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature