Brucker Mary C, King Tekoa L
J Midwifery Womens Health. 2017 May;62(3):308-316. doi: 10.1111/jmwh.12611. Epub 2017 May 29.
As of 2015, the US Food and Drug Administration (FDA) discontinued the pregnancy risk categories (ABCDX) that had been used to denote the putative safety of drugs for use among pregnant women. The ABCDX system has been replaced by the FDA Pregnancy and Lactation Labeling Rule (PLLR) that requires narrative text to describe risk information, clinical considerations, and background data for the drug. The new rule includes 3 overarching categories: 1) pregnancy, which includes labor and birth; 2) lactation; and 3) females and males of reproductive potential. This article reviews the key components of the PLLR and clinical implications, and provides resources for clinicians who prescribe drugs for women of reproductive age.
截至2015年，美国食品药品监督管理局（FDA）停用了用于表示药物在孕妇中假定安全性的妊娠风险类别（ABCDX）。ABCDX系统已被FDA妊娠和哺乳期标签规则（PLLR）所取代，该规则要求用叙述性文本描述药物的风险信息、临床注意事项和背景数据。新规则包括3个总体类别：1）妊娠，包括分娩；2）哺乳期；3）有生殖潜力的女性和男性。本文回顾了PLLR的关键组成部分及其临床意义，并为给育龄女性开药的临床医生提供相关资源。
