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The Medication Risk of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis in Asians: The Major Drug Causality and Comparison With the US FDA Label.
- Source :
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Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2019 Jan; Vol. 105 (1), pp. 112-120. Date of Electronic Publication: 2018 Aug 09. - Publication Year :
- 2019
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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.<br /> (© 2018 The American Society for Clinical Pharmacology and Therapeutics.)
- Subjects :
- Allopurinol adverse effects
Anti-Infective Agents adverse effects
Anti-Inflammatory Agents, Non-Steroidal adverse effects
Anticonvulsants adverse effects
Antipsychotic Agents adverse effects
Cohort Studies
Free Radical Scavengers adverse effects
Humans
Registries
Risk Factors
Stevens-Johnson Syndrome genetics
United States epidemiology
Asian People genetics
Drug Labeling standards
Stevens-Johnson Syndrome diagnosis
Stevens-Johnson Syndrome epidemiology
United States Food and Drug Administration standards
Subjects
Details
- Language :
- English
- ISSN :
- 1532-6535
- Volume :
- 105
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Clinical pharmacology and therapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 29569740
- Full Text :
- https://doi.org/10.1002/cpt.1071