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Analysis of Individual Case Safety Reports of Severe Cutaneous Adverse Reactions in Korea

강혜련|강민규|손경희|강동윤|박한기|양민석|이주연
연세대학교의과대학 (Yonsei University College of Medicine)|2019.02|Yonsei Medical Journal|제60권 제2호|pp. 208-215|DOI 10.3349/ymj.2019.60.2.208

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키워드

PharmacovigilanceStevens-Johnson syndrometoxic epidermal necrolysisdrug hypersensitivity syndrome
주제분류의학일반

초록

Purpose: Despite morbidities and fatalities, nationwide epidemiologic data for severe cutaneous adverse reactions (SCARs), includingStevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemicsymptoms (DRESS), are not widely available. We aimed to investigate SCAR epidemiology over the last two decades in Korea. Materials and Methods: We analyzed individual case safety reports (ICSRs) of SCARs in the Korea Adverse Event Reporting Systemfrom 1988 to 2013. Administered drugs, demographic profiles, and causality assessment according to the World Health Organization-Uppsala Monitoring Center system were analyzed. Results: A total of 755 SCAR cases (508 SJS/TEN, 247 DRESS) were reported. The number of SCAR ICSRs has been increasingwith increasing ICSRs for overall adverse drug events. Since 2010, the number of SCAR ICSRs has increased up to 100 cases/year. Allopurinol was the most common causative drug (SJS/TEN: 10.2%; DRESS: 11.3%; SCAR ICSRs: 10.6%), followed by carbamazepine(SJS/TEN: 8.7%; DRESS: 9.7%; SCAR ICSRs: 8.6%). Regarding drug groups, antiepileptics (19.5%) and antibiotics for systemicuse (12.7%) were common causative drug groups. Twenty SCAR-related deaths were recorded. Antibacterials were the mostcommon causes of deaths (8 cases), followed by antiepileptics (5 cases). The potential risk of SCARs was not specified in the druginformation leaflet for 40.2% of drugs causing SJS/TEN and 82.5% causing DRESS syndrome in Korea. Conclusion: The number of SCAR ICSRs has increased rapidly with recent active pharmacovigilance programs in Korea. Allopurinoland antiepileptics are the most common individual and categorical causative agents, respectively.

Abstract

Purpose: Despite morbidities and fatalities, nationwide epidemiologic data for severe cutaneous adverse reactions (SCARs), includingStevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemicsymptoms (DRESS), are not widely available. We aimed to investigate SCAR epidemiology over the last two decades in Korea. Materials and Methods: We analyzed individual case safety reports (ICSRs) of SCARs in the Korea Adverse Event Reporting Systemfrom 1988 to 2013. Administered drugs, demographic profiles, and causality assessment according to the World Health Organization-Uppsala Monitoring Center system were analyzed. Results: A total of 755 SCAR cases (508 SJS/TEN, 247 DRESS) were reported. The number of SCAR ICSRs has been increasingwith increasing ICSRs for overall adverse drug events. Since 2010, the number of SCAR ICSRs has increased up to 100 cases/year. Allopurinol was the most common causative drug (SJS/TEN: 10.2%; DRESS: 11.3%; SCAR ICSRs: 10.6%), followed by carbamazepine(SJS/TEN: 8.7%; DRESS: 9.7%; SCAR ICSRs: 8.6%). Regarding drug groups, antiepileptics (19.5%) and antibiotics for systemicuse (12.7%) were common causative drug groups. Twenty SCAR-related deaths were recorded. Antibacterials were the mostcommon causes of deaths (8 cases), followed by antiepileptics (5 cases). The potential risk of SCARs was not specified in the druginformation leaflet for 40.2% of drugs causing SJS/TEN and 82.5% causing DRESS syndrome in Korea. Conclusion: The number of SCAR ICSRs has increased rapidly with recent active pharmacovigilance programs in Korea. Allopurinoland antiepileptics are the most common individual and categorical causative agents, respectively.

참고문헌 (27)

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