Assessing carbamazepine and oxcarbazepine‐associated Stevens‐Johnson syndrome/toxic epidermal necrolysis: Data mining the public version of the FDA adverse event reporting system

作者：Caibing Xu, Lingyun Pan, Yuxia Zhang, Jinghua Zhang, Qiuyan Sun, Wei Fang · 发表于：International Journal of Clinical Practice · 年份：2021 · DOI：10.1111/ijcp.14273 · 被引用次数：10 · 研究领域：Drug-Induced Adverse Reactions、Pharmacovigilance and Adverse Drug Reactions、Contact Dermatitis and Allergies

AIMS: Stevens-Johnson syndrome and toxic epidermal necrolysis are viewed as the most severe drug-induced types of cutaneous adverse reactions, with high rates of morbidity and mortality. We aimed to examine carbamazepine- and oxcarbazepine-associated Stevens-Johnson syndrome or toxic epidermal necrolysis, by data mining the US Food and Drug Administration Adverse Event Reporting System (FAERS). METHODS: Reports in FAERs were analysed, from the first quarter of 2004 to the last quarter of 2019. Pharmacovigilance tools were employed for the quantitative detection of signals, where a signal represents a drug-associated adverse event, including the reporting odds ratio, proportional reporting ratio, an information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. RESULTS: The total number of reports identified as Stevens-Johnson syndrome or toxic epidermal necrolysis associated with carbamazepine or oxcarbazepine included in this study was 1231. FAERS reports associated with carbamazepine were 1048, including Stevens-Johnson syndrome (n = 668) and toxic epidermal necrolysis(n = 380). FAERS reports associated with oxcarbazepine were 183, including 142 Stevens-Johnson syndrome and 41 toxic epidermal necrolysis reports. The risk for Stevens-Johnson syndrome is higher than for toxic epidermal necrolysis and carbamazepine is associated with a higher risk than oxcarbazepine. CONCLUSIONS: The results of our study are consistent ...