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Updates to the US Food and Drug Administration Regulations for Mifepristone: Implications for Clinical Practice and Access to Abortion.

Authors :
Simmonds KE
Beal MW
Eagen-Torkko MK
Source :
Journal of midwifery & women's health [J Midwifery Womens Health] 2017 May; Vol. 62 (3), pp. 348-352.
Publication Year :
2017

Abstract

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.<br /> (© 2017 by the American College of Nurse-Midwives.)

Details

Language :
English
ISSN :
1542-2011
Volume :
62
Issue :
3
Database :
MEDLINE
Journal :
Journal of midwifery & women's health
Publication Type :
Academic Journal
Accession number :
28632953
Full Text :
https://doi.org/10.1111/jmwh.12636