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KMID : 1011320210130020070
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Journal of Pharmacoepidemiology and Risk Management
2021 Volume.13 No. 2 p.70 ~ p.77
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Drug Labeling Status of Culprit Drugs Inducing Severe Cutaneous Adverse Reactions
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Yeom Hui-Jong
Kim Hyun-Hwa
Kim Hyun-Jee
Park Soo-Been
Jang Ji-Young
Park Ga-Yoon
Kang Dong-Yoon
Kang Hye-Ryun
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Abstract
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Objective: The labeling status of culprit drugs of Severe Cutaneous Adverse Reactions (SCAR) was evaluated by comparing the labeling status of the US Food and Drug Administration (FDA) to the adverse reaction information listed in Micromedexⓡ.
Methods: Based on the KoSCAR registry, culprit drugs of SCARs in Korea were assessed from 2010 to 2020 using the labeling status of the Korean Ministry of Food and Drug Safety (MFDS) and the FDA. Micromedexⓡ was also used to evaluate the SCAR-inducing potential of each drug.
Results: Among the 292 different culprit drugs registered in the KoSCAR registry, drugs listed at least twice were included. Number of culprit drugs was 109 for Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and 85 for drug reaction with eosinophilia and systemic symptoms (DRESS). Meanwhile, 23 culprit drugs for SJS/TEN and 49 drugs for DRESS were missing labels in the registry. Among these unlabeled drugs, propranolol, risperidone (in SJS/TEN), etodolac, lithium, mefenamic acid, meloxicam, metronidazole, and naproxen (in DRESS) were included in the US FDA drug labeling. Although 11 drugs for SJS/TEN cases and 31 drugs for DRESS cases were repeatedly reported as culprit agents, they were not labeled in either Korean MFDS or US UFDA. Among these drugs, ethambutol was listed as a culprit drug for SJS/TEN in Micromedexⓡ.
Conclusion: The labelling of drugs associated with SCARs need to be updated based on findings from domestic cases and global databases.
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KEYWORD
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Drug-related side effects and adverse reactions, Adverse drug reaction reporting system, Pharmacovigilance, Stevens-Johnson Syndrome, Drug Hypersensitivity Syndrome
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