未经批准:我们试图描述与未经批准的局部痣和含有浓水杨酸的皮肤标签去除剂相关的皮肤损伤,加拿大血根病,或其他腐蚀性试剂。
UNASSIGNED:我们确定了在2021年10月30日之前向美国食品和药物管理局(FDA)报告的未经批准的非设备局部痣和皮肤标签去除剂相关的皮肤损伤,或在2019年至2021年之间的亚马逊消费者产品评论中描述。
未经评估:我们确定了38例,包括来自亚马逊消费者产品评论的30份和向FDA报告的8份。从2021年开始,有28个。使用的最常见原因是去除痣和/或皮肤标签。列出的成分包括水杨酸,加拿大血根病,植物药(包括顺势疗法产品),和氧化钙。七个案例涉及未列出成分的产品。不良事件包括烧伤,疼痛,和溃疡,一些导致永久性疤痕和毁容。有14个面部受伤,包括四个邻近的眼睛。报告的治疗包括抗生素,医院护理,伤口护理,和皮肤科建议做皮肤移植。
未经批准:限制包括向FDA少报不良事件,有限的临床细节和消费者评论中的潜在偏见,由于亚马逊网站的动态性,评论搜索的可复制性差。
未经批准:未经批准,非器械局部痣和皮肤标签去除剂与严重的皮肤损伤有关。我们发现亚马逊消费者评论是一种新颖而有用的数据来源,用于对这些类型的皮肤产品进行安全性监测。当皮肤科医生咨询皮肤损伤时,在鉴别诊断中应考虑这些产品的暴露。
UNASSIGNED: We sought to describe skin injuries associated with unapproved topical
mole and skin tag removers containing concentrated salicylic acid, Sanguinaria canadensis, or other caustic agents.
UNASSIGNED: We identified skin injuries associated with unapproved non-device topical
mole and skin tag removers reported to the US Food and Drug Administration (FDA) through October 30, 2021 or described in Amazon consumer product reviews between 2019 and 2021.
UNASSIGNED: We identified 38 cases, including 30 from Amazon consumer product reviews and eight reported to the FDA. Twenty-eight were from 2021. The most common reason for use was for
mole and/or skin tag removal. Listed ingredients included salicylic acid, Sanguinaria canadensis, botanicals (includes homeopathic products), and calcium oxide. Seven cases involved products without ingredients listed. Adverse events included burns, pain, and ulceration, some resulting in permanent scarring and disfigurement. There were 14 facial injuries, including four adjacent to the eye. Reported treatments included antibiotics, hospital care, wound care, and dermatology advice to have a skin graft.
UNASSIGNED: Limitations include underreporting of adverse events to the FDA, limited clinical details and potential bias in consumer reviews, and poor replicability of review searches due to the dynamic nature of the Amazon website.
UNASSIGNED: Unapproved, non-device topical
mole and skin tag removers are associated with serious skin injuries. We found Amazon consumer reviews to be a novel and useful data source for safety surveillance of these types of skin products. When dermatologists are consulted about skin injuries, exposure to these products should be considered in the differential diagnosis.