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Spontaneously reported hepatic adverse drug events in Korea: multicenter study

Authors
 Hee Kwon  ;  Suk-Hyang Lee  ;  Seong-Eun Kim  ;  Jae-Hyun Lee  ;  Yung-Koo Jee  ;  Hye-Ryun Kang  ;  Byung-Joo Park  ;  Jung-Won Park  ;  Chein-Soo Hong 
Citation
 JOURNAL OF KOREAN MEDICAL SCIENCE, Vol.27(3) : 268-273, 2012 
Journal Title
 JOURNAL OF KOREAN MEDICAL SCIENCE 
ISSN
 1011-8934 
Issue Date
2012
MeSH
Adult ; Adverse Drug Reaction Reporting Systems*/statistics & numerical data ; Aged ; Anti-Infective Agents/adverse effects ; Anti-Inflammatory Agents, Non-Steroidal/adverse effects ; Anticonvulsants/adverse effects ; Chemical and Drug Induced Liver Injury/epidemiology* ; Chemical and Drug Induced Liver Injury/etiology* ; Drug Monitoring ; Female ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects ; Male ; Middle Aged ; Odds Ratio ; Pharmacovigilance ; Republic of Korea/epidemiology ; Risk Factors
Keywords
Drug-Induced Hepatitis ; Etiology ; Spontaneous Pharmacovigilance
Abstract
Hepatic adverse drug reactions (ADRs) to certain drugs may differ within each country, reflecting different patterns of prescription, socioeconomic status, and culture. The purpose of this study was to assess the suspected cause of hepatic ADRs using the spontaneously reported pharmacovigilance data from Korea. A total of 9,360 spontaneously reported adverse drug events (ADEs) from nine Pharmacovigilance Centers were analyzed. Risk of hepatic ADEs was assessed by calculating the reporting odds ratio (ROR). Of the 9,360 cases, 567 hepatic ADEs were reported. The most frequently prescribed drug classes inducing hepatic ADEs were anti-tuberculotics, cephalosporins, valproic acids, penicillins, quinolones, non-steroidal anti-inflammatory drugs (NSAIDs), anti-viral agents, and statins. ROR values were especially high in anti-tuberculosis drugs, systemic antifungal drugs for systemic use, anti-epileptics, propylthiouracil, and herbal medicines. Underlying diseases such as tuberculosis (6.9% vs 0.9%), pneumonia (4.9% vs 1.7%), intracranial injury including skull fracture (4.5% vs 0.9%), HIV (3.4% vs 0.4%), subarachnoid hemorrhage (2.8% vs 0.5%), and osteoporosis (2.4% vs 1.4%) were significantly more common in hepatic ADE group. In conclusion, anti-infective drugs, anti-epileptics, NSAIDs and statins are the most common suspects of the spontaneously reported hepatic ADEs, in Korea. Careful monitoring for such reactions is needed for the prescription of these drugs.
Files in This Item:
T201201881.pdf Download
DOI
22379337
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Jung Won(박중원) ORCID logo https://orcid.org/0000-0003-0249-8749
Lee, Jae Hyun(이재현) ORCID logo https://orcid.org/0000-0002-0760-0071
Hong, Chein Soo(홍천수)
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/90892
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