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Cutaneous Adverse Events in Newly Approved FDA Non-cancer Drugs: A Systematic Review.
Drugs in R&D ( IF 2.2 ) Pub Date : 2020-06-17 , DOI: 10.1007/s40268-020-00311-6
Paul C Macklis 1 , Brittany Dulmage 1 , Brady Evans 1 , Misha Rosenbach 2 , Johann E Gudjonsson 3 , Benjamin H Kaffenberger 1
Affiliation  

The prevalence of cutaneous adverse events attributable to newly approved anti-cancer drugs has been well reviewed in the dermatologic literature. In contrast, over 75% of US Food and Drug Administration approvals in the past 5 years have been for non-cancer drugs and indications. This represents multiple other categories of approved medications associated with cutaneous adverse reactions. To investigate the cutaneous adverse events associated with these potentially neglected medications, a systematic review was conducted. Two hundred and forty-one medications approved by the Food and Drug Administration between 2013 and 2018 were reviewed and 180 non-oncologic drugs were identified. The prescribing information for each medication was reviewed for the presence of cutaneous adverse events and a supplemental literature search was performed to better characterize any adverse events outlined within the prescribing information. Most reactions were classified as morbilliform, macular, popular, or maculopapular. Fortunately, only a few severe cutaneous adverse reactions were reported, namely in benznidazole, cannabidiol, and sofosbuvir. This review summarizes available data drawn from clinical trials and case reports involving cutaneous adverse events from the 21 non-oncologic medications associated with cutaneous adverse events.



中文翻译:


FDA 新批准的非癌症药物中的皮肤不良事件:系统评价。



皮肤病学文献对新批准的抗癌药物引起的皮肤不良事件的发生率进行了充分的回顾。相比之下,美国食品和药物管理局过去 5 年批准的药物中有 75% 以上是针对非癌症药物和适应症。这代表了与皮肤不良反应相关的多种其他类别的批准药物。为了调查与这些可能被忽视的药物相关的皮肤不良事件,进行了系统评价。对 2013 年至 2018 年间美国食品药品监督管理局批准的 241 种药物进行了审查,并确定了 180 种非肿瘤药物。审查了每种药物的处方信息是否存在皮肤不良事件,并进行了补充文献检索,以更好地表征处方信息中概述的任何不良事件。大多数反应被分类为麻疹样反应、黄斑反应、流行反应或斑丘疹反应。幸运的是,仅报告了少数严重皮肤不良反应,即苯硝唑、大麻二酚和索磷布韦。本综述总结了从涉及 21 种与皮肤不良事件相关的非肿瘤药物中涉及皮肤不良事件的临床试验和病例报告中提取的可用数据。

更新日期:2020-07-24
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