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Korean J Med > Volume 86(6); 2014 > Article
The Korean Journal of Medicine 2014;86(6): 710-721.
약물유해사례 자발보고자료를 통한 국내 중증피부유해반응 원인 약물 분석
김미영1,2, 양민석1,3, 강혜련1,4, 조상헌1,4, 민경업1,4
1서울대학교 의학연구원 알레르기 및 임상면역연구소
2인제대학교 의과대학 부산백병원 내과
3서울특별시 보라매병원 내과
4서울대학교 의과대학 서울대학교병원 내과
Analysis of Drugs Causing Severe Cutaneous Adverse Reactions, Based on the Korean Database of Spontaneously Reported Adverse Drug Reactions
Mi-Yeong Kim1,2, Min-Suk Yang1,3, Hye-Ryun Kang1,4, Sang-Heon Cho1,4, Kyung-Up Min1,4
1Institute of Allergy and Clinical Immunology, Seoul National University Medical Research Center, Seoul, Korea
2Department of Internal Medicine, Busan Paik Hospital, Inje University College of Medicine, Busan, Korea
3Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea
4Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
Corresponding Author: Kyung-Up Min ,Tel: +82-2-2072-3286, Fax: +82-2-762-9662, Email: drmin@snu.ac.kr
Received: October 4, 2013;   Revised: November 18, 2013;   Accepted: December 31, 2013.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
ABSTRACT
Background/Aims:
Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) are severe cutaneous adverse reactions (SCARs) that also affect the internal organs with high mortality. However, there has been no previous nationwide study of SCARs in Korea.
Methods:
Cases of SCARs were recruited from the nationwide Korean Pharmacovigilance Research Network database, collected from June 2009 to December 2010, by a spontaneous reporting system. We analyzed age, gender, route of administration and the causative agents. We also reviewed previously published cases of SCARs in Korea.
Results:
In total, 100 cases of SJS (66 cases), TEN (7 cases), and DRESS (27 cases) were reported. The mean age of the patients was 54.1 ± 19.8 years and the proportion of males to females was 1:0.88. In total, 81 drugs were reported as causative agents: SJS (61 drugs), TEN (15 drugs), and DRESS (29 drugs). The most commonly reported causative drug was allopurinol (12 cases). Allopurinol (8 cases) and levofloxacin (2 cases) were the most commonly reported causative drugs for SJS and TEN, respectively. In DRESS, allopurinol (4 cases) and vancomycin (4 cases) were the two most common causative drugs. Anti-infective drugs were the most common drug category (75 cases). Carbamazepine was the most commonly reported causative drug according to published cases in Korea.
Conclusions:
Allopurinol in the spontaneous reporting system and carbamazepine in the published cases were the most common single causative drugs in SCARs in Korea. Anti-infectives were the most common drug category in the spontaneous reporting system. (Korean J Med 2014;86:710-721)
Keywords: Stevens-Johnson syndrome; Pharmacovigilance; Drug hypersensitivity; Eosinophilia
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