The Medication Risk of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis in Asians: The Major Drug Causality and Comparison With the US FDA Label

Wang YH 1 , Chen CB 1 , Tassaneeyakul W 2 , Saito Y 3 , Aihara M 4 , Choon SE 5 Show all authors , Lee HY 6 , Chang MM 7 , Roa FD 8 , Wu CW 9 , Zhang J 10 , Nakkam N 2 , Konyoung P 11 , Okamoto-Uchida Y 3 , Cheung CM 7 , Huang JW 10 , Ji C 10 , Cheng B 10 , Hui RC 1 , Chu CY 12 , Chen YJ 13 , Wu CY 14 , Hsu CK 15 , Chiu TM 16 , Huang YH 1 , Lu CW 1 , Yang CY 1 , Lin YT 1 , Chi MH 1 , Ho HC 1 , Lin JY 1 , Yang CH 1 , Chang YC 1 , Su SC 1 , Wang CW 1 , Fan WL 17 , Hung SI 18 , Chung WH 1 , Asian Severe Cutaneous Adverse Reaction Consortium

Affiliations 

  • 1 Chang Gung Memorial Hospital, Linkou, Taiwan
  • 2 Department of Pharmacology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
  • 3 Division of Medicinal Safety Science, National Institute of Health Sciences, Japan
  • 4 Department of Environmental Immuno-Dermatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan
  • 5 Hospital Sultanah Aminah Johor Bahru, Clinical School of Medicine and Health Sciences, Monash University Malaysia
  • 6 Department of Dermatology, Singapore General Hospital, Singapore
  • 7 Division of Dermatology, Department of Medicine and Therapeutics, Prince of Wales Hospital, the Chinese University of Hong Kong
  • 8 University of the Philippines-Philippine, General Hospital, Manila, Philippines
  • 9 Chang Gung Memorial Hospital, Kaohsiung, Taiwan
  • 10 Department of Dermatology, the First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China
  • 11 Pharmacy Unit, Udon Thani Hospital, Udon Thani, Thailand
  • 12 Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan
  • 13 Department of Dermatology, Taichung Veterans General Hospital, National Yang Ming University, Taichung, Taiwan
  • 14 Department of dermatology, municipal Ta-Tong hospital, Kaohsiung medical university, Taiwan
  • 15 Department of Dermatology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
  • 16 Department of Dermatology, Changhua Christian Hospital, Changhua, Taiwan
  • 17 Whole-Genome Research Core Laboratory of Human Diseases, Chang Gung Memorial Hospital, Keelung, Taiwan
  • 18 Institute of Pharmacology, School of Medicine, National Yang-Ming University, Taipei, Taiwan
Clin. Pharmacol. Ther., 2019 01;105(1):112-120.
PMID: 29569740 DOI: 10.1002/cpt.1071

Abstract

Specific ethnic genetic backgrounds are associated with the risk of Stevens-Johnson syndrome / toxic epidermal necrolysis (SJS/TEN) especially in Asians. However, there have been no large cohort, multiple-country epidemiological studies of medication risk related to SJS/TEN in Asian populations. Thus, we analyzed the registration databases from multiple Asian countries who were treated during 1998-2017. A total 1,028 SJS/TEN cases were identified with the algorithm of drug causality for epidermal necrolysis. Furthermore, those medications labeled by the US Food and Drug Administration (FDA) as carrying a risk of SJS/TEN were also compared with the common causes of SJS/TEN in Asian countries. Oxcarbazepine, sulfasalazine, COX-II inhibitors, and strontium ranelate were identified as new potential causes. In addition to sulfa drugs and beta-lactam antibiotics, quinolones were also a common cause. Only one acetaminophen-induced SJS was identified, while several medications (e.g., oseltamivir, terbinafine, isotretinoin, and sorafenib) labeled as carrying a risk of SJS/TEN by the FDA were not found to have caused any of the cases in the Asian countries investigated in this study.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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