Abstract
Purpose
Materials and Methods
Results
ACKNOWLEDGEMENTS
Notes
Conceptualization: Min-Gyu Kang, Han-Ki Park, Hye-Ryun Kang.
Data curation: Min-Gyu Kang, Han-Ki Park.
Formal analysis: Min-Gyu Kang, Han-Ki Park.
Funding acquisition: Min-Gyu Kang, Hye-Ryun Kang.
Investigation: Min-Gyu Kang, Hani-Ki Park, Hye-Ryun Kang.
Methodology: Min-Gyu Kang, Dong-Yoon Kang, Min-Seok Yang, Kyung-Hee Sohn.
Project administration: Min-Gyu Kang.
Resources: Min-Gyu Kang, Han-Ki Park.
Software: Min-Gyu Kang.
Supervision: Min-Seok Yang, Hye-Ryun Kang, Ju-Yeun Lee.
Validation: Min-Gyu Kang, Kyung-Hee Sohn, Ju-Yeun Lee.
Visualization: Min-Gyu Kang.
Writing—original draft: Min-Gyu Kang, Hye-Ryun Kang.
Writing—review & editing: Min-Gyu Kang, Dong-Yoon Kang, Min-Seok Yang, Ju-Yeun Lee, Han-Ki Park, Kyung-Hee Sohn, Hye-Ryun Kang.
References
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
![crossref](/image/icon/bnr_ref_cross.gif)
Fig. 1
Scheme of the selection process for ICSRs of SCARs in the KIDS-KD. ICSRs, individual case safety reports; SCARs, severe cutaneous adverse reactions; KIDS-KD, Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System database; ADE, adverse drug event; SJS, Stevens-Johnson syndrome; TEN, toxic epidermal necrolysis; DRESS syndrome, drug reaction with eosinophilia and systemic symptoms syndrome; DHS, drug hypersensitivity syndrome; WHO-ART, World Health Organization Adverse Reactions Terminology.
![ymj-60-208-g001](/upload/SynapseXML/0069ymj/thumb/ymj-60-208-g001.jpg)
Fig. 2
Trends in annual numbers of ICSRs of SCARs in KAERS. ICSRs, individual case safety reports; SCARS, severe cutaneous adverse reactions; KAERS, Korea Adverse Event Reporting System; SJS, Stevens-Johnson syndrome; TEN, toxic epidermal necrolysis; DRESS syndrome, drug reaction with eosinophilia and systemic symptoms syndrome.
![ymj-60-208-g002](/upload/SynapseXML/0069ymj/thumb/ymj-60-208-g002.jpg)
Fig. 3
Proportion of causative drugs for SCARs categorized by the main therapeutic group (second level) per ATC classification. (A) Total, (B) SJS/TEN, (C) DRESS syndrome. SCARs, severe cutaneous adverse reactions; ATC, anatomical therapeutic chemical; SJS, Stevens-Johnson syndrome; TEN, toxic epidermal necrolysis; DRESS syndrome, drug reaction with eosinophilia and systemic symptom syndrome. ATC code: B01 (antithrombotic agents), H02 (corticosteroids for systemic use), J01 (antibacterials for systemic use), J04 (antimycobacterials), L01 (antineoplastic agents), M01 (anti-inflammatory and antirheumatic products), M04 (anti-gout preparations), N02 (analgesics), N03 (antiepileptics), S01 (ophthalmologicals), and undetermined (cases in which two or more drugs were simultaneously reported as a causative agent so that the culprit drug could not be identified).
![ymj-60-208-g003](/upload/SynapseXML/0069ymj/thumb/ymj-60-208-g003.jpg)
Table 1
Baseline Characteristics in Individual Case Safety Reports of SCARs
![ymj-60-208-i001](/upload/SynapseXML/0069ymj/thumb/ymj-60-208-i001.jpg)
Table 2
Common SCAR-Causing Drugs and Drug Labeling Information
![ymj-60-208-i002](/upload/SynapseXML/0069ymj/thumb/ymj-60-208-i002.jpg)
SCARs, severe cutaneous adverse reactions; DRESS syndrome, drug reactions with eosinophilia and systemic symptoms syndrome; SJS/TEN, Stevens-Johnsons syndrome/Toxic epidermal necrolysis.
Others: drugs for which less than three cases were reported. Undetermined: cases in which two or more drugs were simultaneously reported as a causative agent so that the culprit drug could not be identified. TMP/SMX: trimethoprim and sulfamethoxazole.
*Drugs for which the labeling information did not include the risk of SCARs.
Table 3
Summary of Cases of SCAR-Related Deaths and Drug Labeling Information for SCARs
![ymj-60-208-i003](/upload/SynapseXML/0069ymj/thumb/ymj-60-208-i003.jpg)
SCARs, severe cutaneous adverse reactions; DRESS syndrome, drug reactions with eosinophilia and systemic symptom syndrome; SJS/TEN, Stevens-Johnsons syndrome/toxic epidermal necrolysis; ATC, anatomical therapeutic chemical.
*Drugs for which the labeling information did not include the risk of SCARs.