J Pharmacoepidemiol Risk Manage.  2021 Sep;13(2):70-77. 10.56142/2021.13.2.70.

Drug Labeling Status of Culprit Drugs Inducing Severe Cutaneous Adverse Reactions

• Yeom HJ
• Kim HHw
• Kim HJ
• Park S
• Jang JY
• Park GY
• Kang DY
• Kang HR

• KMID: 2534651
• DOI: http://doi.org/10.56142/2021.13.2.70

Abstract

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.

Keyword

Drug-related side effects and adverse reactions; Adverse drug reaction reporting system; Pharmacovigilance; Stevens-Johnson Syndrome; Drug Hypersensitivity Syndrome