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Changes to Pregnancy and Lactation Risk Labeling for Prescription Drugs.

机译:处方药的妊娠和哺乳期风险标签的更改。

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摘要

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.
机译:妇女在怀孕和哺乳期间安全使用药物是妇女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)发布了有关新标签更改的最终规则,该规则于2015年6月生效,并取消了现行的AD X信函系统。新标签将包括对在怀孕和哺乳期间使用药物,并提供支持性数据和相关信息,以帮助医疗保健提供者为孕妇和哺乳期妇女提供咨询。

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