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Updates to the US Food and Drug Administration Regulations for Mifepristone: Implications for Clinical Practice and Access to Abortion
Author(s) -
Simmonds Katherine E.,
Beal Margaret W.,
EagenTorkko Meghan K.
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.12636
Subject(s) - mifepristone , misoprostol , food and drug administration , abortion , medicine , administration (probate law) , medical abortion , clinical practice , obstetrics , family medicine , gynecology , pregnancy , medical emergency , political science , law , genetics , biology
This article provides information on recent changes in the US Food and Drug Administration (FDA) labeling and safety regulations for mifepristone (Mifeprex). The revised label now permits midwives, advanced practice nurses, and physician assistants to order and prescribe mifepristone, eliminating the requirement for physician supervision. The updated label also extends eligibility for use from 49 to 70 days’ gestation and decreases the number of required visits from 3 to 2. The recommended dose of mifepristone has been reduced, and the dosage, timing, and route of administration for misoprostol have also been changed to reflect current research. These changes have implications for clinical practice and may lead to expanded access for women in the United States.