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The 2015 US Food and Drug Administration Pregnancy and Lactation Labeling Rule
Author(s) -
Brucker Mary C.,
King Tekoa L.
Publication year - 2017
Publication title -
journal of midwifery and women's health
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.543
H-Index - 62
eISSN - 1542-2011
pISSN - 1526-9523
DOI - 10.1111/jmwh.12611
Subject(s) - pregnancy , food and drug administration , lactation , medicine , drug , obstetrics , narrative review , environmental health , intensive care medicine , pharmacology , biology , genetics
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 The ABCDX system has been replaced by the FDA Pregnancy and Lactation Labeling Rule (PLLR) that requires narrative text to describe risk information, clinical considerations, and background data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.