妊娠期皮肤药物安全

Thu M. Truong, Marita Yaghi, Jenny E. Murase
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引用次数: 0

摘要

2014年,美国FDA取消了妊娠类药品字母制度,并颁布了《妊娠和哺乳标签裁定》。该裁决要求药品包含药物特定暴露妊娠登记的联系信息,总结妊娠已知影响的叙述性部分,哺乳期咨询数据,以及描述女性和男性生殖潜力风险的数据。这项新规定为医患决策过程增加了更多的对话和讨论,并要求临床医生根据当前的医学文献提供更多的个性化咨询。这篇文章总结了最近对孕妇和哺乳期妇女最常见的皮肤科治疗的安全性的证据。
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Dermatologic Drug Safety in Pregnancy
In 2014, the US FDA removed the Pregnancy Category Drug lettering system and enacted the “Pregnancy and Lactation Label Ruling.” This ruling required drug products to contain contact information for drug-specific exposure pregnancy registries, narrative-style sections summarizing the known effect of pregnancy, lactation counseling data, and data describing risks for females and males of reproductive potential. This new ruling has added more dialogue and discussion to the patient-provider decision-making process and equires clinicians to provide more individualized counseling based on the current medical literature. This article summarizes the recent evidence for the safety of the most common dermatological therapies for pregnant and lactating women.
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