Pediatric and Maternal Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA. .
Am J Med Genet C Semin Med Genet. 2011 Aug 15;157C(3):209-14. doi: 10.1002/ajmg.c.30304. Epub 2011 Jul 15.
Pregnant women should have access to medications that have been adequately studied for use to facilitate evidence-based risk-benefit discussions with their health care providers. Pregnant women experience acute medical emergencies, have existing conditions that require continued medical treatment or may develop pregnancy-induced conditions, making drug use during pregnancy unavoidable. Drug labeling is the primary source of information about a drug's use. The safety and efficacy data found in the label is derived from well-controlled clinical trials conducted prior to a drug's approval. However, pregnant women are rarely enrolled in clinical trials unless a product is specifically indicated for a pregnancy-related condition. Consequently, information regarding a product's use during pregnancy is usually collected postapproval. Current data collection tools include pregnancy exposure registries, retrospective cohort studies, pregnancy surveillance programs, case-control studies, spontaneous reports of adverse events and case reports. Each tool has strengths and limitations in its ability to detect teratogenic signals. Combinations of different sources of data are necessary to acquire the most complete picture of potential teratogenic risk, as no single method can capture all desired data to help pregnant patients and women of child bearing potential make appropriate risk benefits decisions along with their health care providers.
孕妇应能够获得经过充分研究可用于药物，以便与医疗保健提供者进行基于证据的风险效益讨论。孕妇会经历急性医疗紧急情况，有需要继续治疗的现有疾病，或可能会出现妊娠引起的疾病，因此在怀孕期间使用药物是不可避免的。药物标签是药物使用的主要信息来源。标签中找到的安全性和有效性数据是从药物获得批准之前进行的精心控制的临床试验中得出的。但是，除非产品专门用于与妊娠相关的病症，否则很少有孕妇被纳入临床试验。因此，有关产品在怀孕期间使用的信息通常是在批准后收集的。当前的数据收集工具包括妊娠暴露登记处、回顾性队列研究、妊娠监测计划、病例对照研究、不良事件自发报告和病例报告。每种工具在检测致畸信号方面的能力都有其优势和局限性。需要结合不同来源的数据来获得潜在致畸风险的最完整图片，因为没有单一的方法可以捕获所有所需的数据，以帮助孕妇和有生育潜力的妇女与其医疗保健提供者一起做出适当的风险效益决策。
