Signal Detection of Imipenem Compared to Other Drugs from Korea Adverse Event Reporting System Database

Park, Kyounghoon; Soukavong, Mick; Kim, Jungmee; Kwon, Kilsung; Jin, Xueying; Lee, Joongyub; Yang, Bo; Park, Byung Joo

doi:10.3349/ymj.2017.58.3.564

Cited by 12 publications

(9 citation statements)

References 24 publications

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“…A national pharmacovigilance database enables detection of unknown ADRs in addition to known ADRs. The KIDS-KD has been successfully used to detect signals of several drugs including imipenem and quinolone antibiotics [ 24 , 25 ]. In this study, we were able to detect signals of cephalosporins.…”

Section: Discussionmentioning

confidence: 99%

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

Choi

Kim

et al. 2021

Pharmaceuticals

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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.

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Section: Discussionmentioning

confidence: 99%

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

Choi

Kim

et al. 2021

Pharmaceuticals

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“…8 Research with this method is usually performed to detect unexpected ADRs that are not found in the list of well-documented ADRs found on the drug label information. 27–29 Therefore, continuous monitoring is needed along with cooperation with other epidemiologic studies on drug safety.…”

Section: Discussionmentioning

confidence: 99%

Comparison of bleeding risks among non-vitamin K antagonist oral anticoagulants using the Korea adverse event reporting system database

Kim

Park

et al. 2019

Therapeutic Advances in Drug Safety

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Background: In order to ensure safer use of non-vitamin K antagonist oral anticoagulants (NOACs), continuously detecting unexpected adverse drug reactions (ADRs) after market approval is necessary. Methods: We performed disproportionality analysis to evaluate association between ADRs and NOACs including apixaban, dabigatran, and rivaroxaban using data from the Korea Institute of Drug Safety and Risk Management–Korea Adverse Event Reporting System database (KIDS-KD) between 2012 and 2016. There was no significant signal other than bleeding when considering quantity, signal strength, seriousness, and causality. In order to evaluate the NOAC reports about bleeding, we selected 62 WHO-ART diagnostic codes associated with bleeding. Among the 26 codes that referred to major bleeding, 18 codes referred to gastrointestinal bleeding and 8 were referred to intracranial bleeding. We evaluated the significance of the signals using reporting odds ratios (RORs) adjusted for age and sex. Results: Treatments with apixaban, dabigatran, and rivaroxaban were associated with 1989, 1668, and 2960 adverse events, respectively. Any type of bleeding with apixaban, dabigatran, rivaroxaban, and warfarin was reported in 174 (8.8%), 209 (12.5%), 523 (17.8%), and 620 (9.5%) events, respectively. For any bleeding, adjusted RORs of apixaban, dabigatran, and rivaroxaban were 0.99 [95% confidence interval (CI): 0.83–1.17], 1.47 (95% CI: 1.25–1.75), and 2.48 (95% CI: 2.16–2.84), respectively. With respect to major bleeding, the adjusted RORs of apixaban, dabigatran, and rivaroxaban were 1.08 (95% CI: 0.82–1.41), 1.46 (95% CI: 1.10–1.90), and 1.82 (95% CI: 1.43–2.32), respectively. Conclusion: Rivaroxaban might have stronger association with bleeding than apixaban and dabigatran.

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“…A signal was considered to be detected by meeting these indices: the number of cases ≥3, the PRR and ROR≥2, Chi-Squared values ≥4. [ 27 ] The IC is a logarithmic value that can be calculated by dividing the probability of drug use and a specific AE occurrence [P (AE, Drug)] by the product of the individual probabilities of drug use and a specific AE occurrence [P(AE)P (Drug)], if the drug use and the specific AE occurrence are independent. This can be expressed as the following formula: IC = log 2 P (AE, Drug)/P (AE)P (Drug).…”

Section: Methodsmentioning

confidence: 99%

Topiramate-related adverse events

Choi¹,

Yoon²,

Park³

et al. 2020

Medicine

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Despite safety concerns associated with topiramate use, the pattern of adverse events and signal analysis of antiepileptic drugs remain elusive. We aimed to determine patient demographics and characteristics of reported AEs of topiramate and to detect the associated signals by comparing those of other antiepileptics. We used the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) from 2010 to 2017 to determine patient demographics and characteristics of reported AEs for topiramate and other antiepileptics. The proportional reporting ratio, reporting odds ratio, and information component were used in signal detection. Signals were compared against drug labels in Korea, the UK, the EU, and the US. A total of 1300 adverse events cases of topiramate were reported, and the number of topiramate-adverse event pairs was 1861. For topiramate, the proportion of women of childbearing age (20-39 years) with adverse events was more than double that for other antiepileptics. A majority of the 36 detected signals were of neuropsychiatric disorders such as cognitive disorders, concentration impaired, amnesia, hypoaesthesia. Patients with topiramate-induced adverse events were likely to be young and female. Also, adverse events related to carbonic anhydrase isoenzyme showed specifically great disproportionalities. Rigorous clinical management is needed to ensure proper and safe use of topiramate. Special precautions should be taken when prescribing in women of childbearing age.

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Signal Detection of Imipenem Compared to Other Drugs from Korea Adverse Event Reporting System Database

Cited by 12 publications

References 24 publications

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

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

Comparison of bleeding risks among non-vitamin K antagonist oral anticoagulants using the Korea adverse event reporting system database

Topiramate-related adverse events

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