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处方药妊娠和哺乳期风险标签的变更。

Changes to Pregnancy and Lactation Risk Labeling for Prescription Drugs.

作者信息

Fantasia Heidi Collins, Harris Allyssa L

出版信息

Nurs Womens Health. 2015 Jun-Jul;19(3):266-70. doi: 10.1111/1751-486X.12209.

DOI:10.1111/1751-486X.12209
PMID:26058910
Abstract

Safe medication use by women during pregnancy and lactation is an area of concern for women and their health care providers. In December 2014, the U.S. Food and Drug Administration (FDA) issued a final rule on new labeling changes, which go into effect in June 2015 and eliminate the current letter system of A-D, X. The new labeling will include a summary of risks to using the medication during pregnancy and lactation, and supporting data and relevant information to assist health care providers in counseling pregnant and lactating women.

摘要

孕期和哺乳期女性安全用药是女性及其医疗保健提供者关注的领域。2014年12月,美国食品药品监督管理局(FDA)发布了关于新标签变更的最终规定,该规定于2015年6月生效,取消了现行的A-D、X字母系统。新标签将包括在孕期和哺乳期使用该药物的风险总结,以及支持数据和相关信息,以帮助医疗保健提供者为孕妇和哺乳期妇女提供咨询。

相似文献

1
Changes to Pregnancy and Lactation Risk Labeling for Prescription Drugs.处方药妊娠和哺乳期风险标签的变更。
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引用本文的文献

1
Prescription medication use during pregnancies that resulted in births and abortions (2001-2013): A retrospective population-based study in a Canadian population.妊娠期间(2001-2013 年)导致分娩和流产的处方药物使用情况:加拿大人群中的一项回顾性基于人群的研究。
PLoS One. 2019 Mar 6;14(3):e0211319. doi: 10.1371/journal.pone.0211319. eCollection 2019.
2
Potential Drug Interactions and Drug Risk during Pregnancy and Breastfeeding: An Observational Study in a Women's Health Intensive Care Unit.孕期及哺乳期的潜在药物相互作用与药物风险:一项在女性健康重症监护病房的观察性研究
Rev Bras Ginecol Obstet. 2017 Jun;39(6):258-264. doi: 10.1055/s-0037-1603680. Epub 2017 Jun 1.