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Drug safety: Pregnancy rating classifications and controversies

机译:药物安全性:妊娠等级分类和争议

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This contribution consolidates data on international pregnancy rating classifications, including the former US Food and Drug Administration (FDA), Swedish, and Australian classification systems, as well as the evidence-based medicine system, and discusses discrepancies among them. It reviews the new Pregnancy and Lactation Labeling Rule (PLLR) that replaced the former FDA labeling system with narrative -based labeling requirements. PLLR emphasizes on human data and highlights pregnancy exposure registry information. In this context, the review discusses important data on the safety of most medications used in the management of skin disease in pregnancy. There are also discussions of controversies relevant to the safety of certain dermatologic medications during gestation. (C) 2016 Elsevier Inc. All rights reserved.
机译:该文稿巩固了国际妊娠等级分类的数据,包括前美国食品药品管理局(FDA),瑞典和澳大利亚的分类系统以及循证医学系统,并讨论了其中的差异。它审查了新的怀孕和哺乳标记规则(PLLR),该规则以基于叙事的标记要求代替了以前的FDA标记系统。 PLLR强调人类数据并强调怀孕暴露注册表信息。在这种情况下,本综述讨论了用于治疗孕妇皮肤疾病的大多数药物安全性的重要数据。也有一些与妊娠期某些皮肤科用药安全性有关的争议的讨论。 (C)2016 Elsevier Inc.保留所有权利。

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