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. Cefatrizine–corneal edema (PRR, 440.64; ROR, 481.67; IC, 3.84) and cefatrizine–corneal ulceration (PRR, 346.22; ROR, 399.70; IC, 4.40) had the highest PRR, ROR, and IC among all signals. Additionally, six serious AEs that were not listed on drug labels such as cefaclor-induced stupor (ten cases) and cefaclor-induced respiratory depression (four cases) were found. Detecting signals using a national pharmacovigilance database is useful for identifying unknown ADRs. This study identified signals of cephalosporins that warrant further investigation.

New Adverse Drug Reaction Signals from 2017 to 2021—Genuine Alerts or False Alarms?

“…After applying the inclusion and exclusion criteria, we found 56 new suspected ADRs arising from 24 drugs (involving a wide range of antibiotics, biologics and CNS drugs) [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35]. We then narrowed down the search to focus on more recent articles published within the years 2017-2021.…”

“…Table 2 gives full details of the drugs, new ADR signals as well as details of subsequent citing literature and any further detailed assessment of the ADR signal. After applying the inclusion and exclusion criteria, we found 56 new suspected ADRs arising from 24 drugs (involving a wide range of antibiotics, biologics and CNS drugs) [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35].…”

Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems

“… 36 , 37 KIDS-KD is managed by the KIDS, and studies using that system have increased. 38 , 39 The reports on specific AEs in FAERS use MedDRA, while those in KIDS-KD use WHOART. We exploited these two databases as to whether these two terminologies can be used for the detection of off-label use.…”

Adverse Events of GLP-1 Receptor Agonists for Weight Loss: Twitter and a National Pharmacovigilance Database

“…A 2-by-2 table was constructed from the drug and adverse event combination (Table 1). From the table, proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) were calculated as Table 2 (Choi et al 2021). Signals that met the three criteria of PRR, ROR, and IC were identified.…”