Analysis of Drugs Causing Severe Cutaneous Adverse Reactions, Based on the Korean Database of Spontaneously Reported Adverse Drug Reactions.
- Author:
Mi Yeong KIM
1
;
Min Suk YANG
;
Hye Ryun KANG
;
Sang Heon CHO
;
Kyung Up MIN
Author Information
1. Institute of Allergy and Clinical Immunology, Seoul National University Medical Research Center, Seoul, Korea. drmin@snu.ac.kr
- Publication Type:Original Article
- Keywords:
Stevens-Johnson syndrome;
Pharmacovigilance;
Drug hypersensitivity;
Eosinophilia
- MeSH:
Allopurinol;
Carbamazepine;
Cicatrix;
Drug Hypersensitivity;
Drug Hypersensitivity Syndrome;
Drug-Related Side Effects and Adverse Reactions*;
Eosinophilia;
Female;
Humans;
Korea;
Levofloxacin;
Male;
Mortality;
Pharmacovigilance;
Stevens-Johnson Syndrome;
Vancomycin
- From:Korean Journal of Medicine
2014;86(6):710-721
- CountryRepublic of Korea
- Language:Korean
-
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.
