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药物警戒与史蒂文斯-约翰逊综合征（SJS）/中毒性表皮坏死松解症（TEN）：对美国食品药品监督管理局不良事件报告系统（FAERS）数据库的55年回顾性分析

Pharmacovigilance and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN): 55 Years of Retrospective Analysis of the FDA Adverse Event Reporting System (FAERS) Database.

作者信息

Castellana Eleonora, Budau Patricia Madalina, Chiappetta Maria Rachele

机构信息

University Hospital Città della Salute e della Scienza of Turin, Turin, Piedmont, Italy.

Università degli Studi di Torino, Turin, Piedmont, Italy.

出版信息

Hosp Pharm. 2025 Apr 30:00185787251337610. doi: 10.1177/00185787251337610.

DOI:10.1177/00185787251337610
PMID:40321431
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12043618/
Abstract

This study investigates Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), severe and rare cutaneous adverse reactions often linked to drug use, utilizing data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database collected between 1969 and 2024. The objective is to identify the drugs most frequently associated with these conditions and to analyze trends in reporting over time. A retrospective analysis was conducted on 29 661 136 total adverse event reports, including 39 398 cases (0.13%) related to SJS/TEN. The drugs most commonly associated were classified using the Anatomical Therapeutic Chemical (ATC) system. The analysis included the severity, outcomes, gender, and age distribution of affected patients, focusing on drugs with the highest number of reports and their association with SJS/TEN. Regarding outcomes, their total number exceeds the number of SJS/TEN cases, as a single adverse drug reaction (ADR) can be associated with multiple outcomes. Of the SJS/TEN cases, 97.79% were classified as severe, and 20.86% were fatal. Reports of SJS/TEN have increased significantly over the decades, peaking during the 2018 to 2020 period. The most frequently implicated drugs were Lamotrigine (9.17% of cases), Sulfamethoxazole/Trimethoprim (6.12%), and Allopurinol (5.88%). Other significant drugs included Phenytoin (5.05%), Acetaminophen (4.97%), and Ibuprofen (4.13%). Valdecoxib showed the highest percentage of SJS/TEN cases relative to its total adverse event reports (10.71%). Women were slightly more affected (51.03%) than men (39.30%). The most impacted age group was 18 to 64 years (45.12%), followed by 65 to 85 years (23.16%). Most reports were submitted by healthcare professionals (70.38%). The 55-year retrospective analysis highlights a rising trend in SJS/TEN reporting, attributed to increased awareness and vigilance in pharmacovigilance. These findings emphasize the importance of monitoring high-risk drugs, such as antiepileptics, analgesics, and antibacterials, and implementing strategies to mitigate associated risks. This study underscores the need for ongoing surveillance and education to enhance patient safety.

摘要

本研究利用1969年至2024年期间从美国食品药品监督管理局不良事件报告系统（FAERS）数据库收集的数据，对史蒂文斯-约翰逊综合征（SJS）和中毒性表皮坏死松解症（TEN）这两种通常与药物使用相关的严重且罕见的皮肤不良反应进行调查。目的是确定与这些病症最常相关的药物，并分析报告随时间的趋势。对总共29661136份不良事件报告进行了回顾性分析，其中包括39398例（0.13%）与SJS/TEN相关的病例。使用解剖学治疗学化学（ATC）系统对最常相关的药物进行分类。分析包括受影响患者的严重程度、结局、性别和年龄分布，重点关注报告数量最多的药物及其与SJS/TEN的关联。关于结局，其总数超过了SJS/TEN病例数，因为单一药物不良反应（ADR）可能与多种结局相关。在SJS/TEN病例中，97.79%被归类为严重，20.86%是致命的。几十年来，SJS/TEN的报告显著增加，在2018年至2020年期间达到峰值。最常涉及的药物是拉莫三嗪（占病例的9.17%）、磺胺甲恶唑/甲氧苄啶（6.12%）和别嘌醇（5.88%）。其他重要药物包括苯妥英（5.05%）、对乙酰氨基酚（4.97%）和布洛芬（4.13%）。伐地昔布相对于其总不良事件报告显示出最高的SJS/TEN病例百分比（10.71%）。女性受影响略多于男性（51.03%对39.30%）。受影响最大的年龄组是18至64岁（45.12%），其次是65至85岁（23.16%）。大多数报告由医疗保健专业人员提交（70.38%）。这项55年的回顾性分析突出了SJS/TEN报告的上升趋势，这归因于药物警戒中意识和警惕性的提高。这些发现强调了监测抗癫痫药、镇痛药和抗菌药等高风险药物以及实施降低相关风险策略的重要性。本研究强调了持续监测和教育以提高患者安全性的必要性。

相似文献

[1]
Pharmacovigilance and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN): 55 Years of Retrospective Analysis of the FDA Adverse Event Reporting System (FAERS) Database.

Hosp Pharm. 2025-4-30

[2]
Causes of Drug-Induced Severe Cutaneous Adverse Reaction Epidermal Necrolysis (EN): An Analysis Using FDA Adverse Event Reporting System (FAERS) Database.

Clin Cosmet Investig Dermatol. 2023-8-16

[3]
Stevens-Johnson syndrome and toxic epidermal necrolysis with antiepileptic drugs: An analysis of the US Food and Drug Administration Adverse Event Reporting System.

Epilepsia. 2018-11-5

[4]
Colistin-associated Stevens-Johnson syndrome and toxic epidermal necrolysis reactions: a retrospective case-non-case pharmacovigilance study.

Expert Opin Drug Saf. 2022-8

[5]
Severe cutaneous adverse drug reactions manifesting as Stevens-Johnson syndrome and toxic epidermal necrolysis reported to the national pharmacovigilance center in Nigeria: a database review from 2004 to 2017.

Ther Adv Drug Saf. 2020-2-12

[6]
Association of antibiotics with Stevens-Johnson syndrome and toxic epidermal necrolysis: A real-world pharmacovigilance study.

Int J Antimicrob Agents. 2025-8

[7]
Is acetaminophen associated with a risk of Stevens-Johnson syndrome and toxic epidermal necrolysis? Analysis of the French Pharmacovigilance Database.

Br J Clin Pharmacol. 2017-11-10

[8]
Allopurinol-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: Signal detection and preventability from Vietnam National pharmacovigilance database.

J Clin Pharm Ther. 2022-12

[9]
Incidence, causative factors and mortality rates of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in northern Italy: data from the REACT registry.

Pharmacoepidemiol Drug Saf. 2016-2

[10]
Toxic epidermal necrolysis and Stevens-Johnson syndrome/toxic epidermal necrolysis overlap in pediatric patients with a focus on newer antiepileptic drugs: A 25-year retrospective study at a single tertiary care center.

Pediatr Dermatol. 2021-7

引用本文的文献

[1]
Lamotrigine Therapy: Relation Between Treatment of Bipolar Affective Disorder and Incidence of Stevens-Johnson Syndrome-A Narrative Review of the Existing Literature.

J Clin Med. 2025-6-10

本文引用的文献

[1]
S3 guideline: Diagnosis and treatment of epidermal necrolysis (Stevens-Johnson syndrome and toxic epidermal necrolysis) - Part 1: Diagnosis, initial management, and immunomodulating systemic therapy.

J Dtsch Dermatol Ges. 2024-10

[2]
Potential risk of non-arteritic anterior ischaemic optic neuropathy in semaglutide users: pharmacovigilance insights.

Eur J Hosp Pharm. 2025-2-21

[3]
Adverse events in different administration routes of semaglutide: a pharmacovigilance study based on the FDA adverse event reporting system.

Front Pharmacol. 2024-6-3

[4]
Drugs associated with epidermal necrolysis in children: A World Health Organization pharmacovigilance database analysis.

J Eur Acad Dermatol Venereol. 2024-9

[5]
Impact of the COVID-19 pandemic on the spontaneous reporting and signal detection of adverse drug events.

Sci Rep. 2023-11-1

[6]
Causes of Drug-Induced Severe Cutaneous Adverse Reaction Epidermal Necrolysis (EN): An Analysis Using FDA Adverse Event Reporting System (FAERS) Database.

Clin Cosmet Investig Dermatol. 2023-8-16

[7]
Sex differences in pharmacokinetics predict adverse drug reactions in women.

Biol Sex Differ. 2020-6-5

[8]
Severe cutaneous adverse drug reactions manifesting as Stevens-Johnson syndrome and toxic epidermal necrolysis reported to the national pharmacovigilance center in Nigeria: a database review from 2004 to 2017.

Ther Adv Drug Saf. 2020-2-12

[9]
Stevens-Johnson syndrome and toxic epidermal necrolysis with antiepileptic drugs: An analysis of the US Food and Drug Administration Adverse Event Reporting System.

Epilepsia. 2018-11-5

[10]
Incidence, causative drugs, and economic consequences of drug-induced SJS, TEN, and SJS-TEN overlap and potential drug-drug interactions during treatment: a retrospective analysis at an Indonesian referral hospital.

Ther Clin Risk Manag. 2017-7-21

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