1. Activities at FDA

Drug Use in Pregnancy and Lactation

抄録

Many women experience medical problems during pregnancy and while breast-feeding that require chronic or episodic treatment with prescription medication. Pregnant and lactating women are typically excluded from clinical drug trials. At the time of a drug's initial marketing, there are seldom meaningful human data on the effects of that drug during pregnancy and lactation. Even after years of marketing, data in product labeling regarding use during pregnancy and lactation rarely go beyond the data available at the time of initial marketing.
This paper will describe FDA's approach to pregnant and lactating women including revising regulations for labeling and guidance documents for industry and reviewers pertinent to the collection and interpretation of data in pregnant and lactating women. The consistent application of adequate study designs would improve the data available regarding drug use during pregnancy and lactation. The goal of improved labeling is to provide clinically useful information that aids the health care provider and patient in making decisions about drug use during pregnancy and lactation.