University of Washington in Seattle, and Seattle Children's Hospital, 4800 Sand Point Way NE, Seattle, WA 98105-0371, USA.
Am J Med Genet C Semin Med Genet. 2011 Aug 15;157C(3):175-82. doi: 10.1002/ajmg.c.30313. Epub 2011 Jul 15.
A majority of pregnant women take at least one medication during pregnancy, although the safety of such drugs during pregnancy is not always known. We reviewed the safety during pregnancy of 172 drugs approved by the US Food and Drug Administration (FDA) from 2000 to 2010 using the TERIS risk rating system. We also reviewed safety information for 468 drugs approved by the FDA from 1980 to 2000 to determine if revisions in risk categories had been made in the last 10 years. The teratogenic risk in human pregnancy was "undetermined" for 168 (97.7%) of drug treatments approved between 2000 and 2010. Furthermore, the amount of data available regarding safety in pregnancy was rated as "none" for 126 (73.3%) of these drugs. For those drugs approved between 1980 and 2000, only 23 (5%) changed a full risk category or more in the past 10 years. Sources of data that led to a revised risk were derived from exposure cohort studies performed through record linkage studies, teratogen information services, large population-based case-control studies, and pregnancy registries. The mean time for a treatment initially classified as having an "undetermined" risk to be assigned a more precise risk was 27 years (95% confidence interval 26-28 years). The lack of information needed to assess the safety of drug treatments during human pregnancy remains a serious public health problem. A more active approach to post-marketing surveillance for teratogenic effects is necessary.
大多数孕妇在怀孕期间至少会服用一种药物，但这些药物在怀孕期间的安全性并不总是为人所知。我们使用 TERIS 风险评级系统，回顾了 2000 年至 2010 年期间美国食品和药物管理局 (FDA) 批准的 172 种药物在怀孕期间的安全性。我们还回顾了 1980 年至 2000 年期间 FDA 批准的 468 种药物的安全性信息，以确定过去 10 年中风险类别是否有修订。在 2000 年至 2010 年期间批准的药物治疗中，有 168 种（97.7%）的致畸风险“不确定”。此外，对于其中 126 种（73.3%）药物，关于妊娠期安全性的数据量被评为“无”。对于 1980 年至 2000 年期间批准的药物，只有 23 种（5%）在过去 10 年中改变了完整的风险类别或更多。导致风险修订的数据源来自通过记录链接研究、致畸信息服务、大型基于人群的病例对照研究和妊娠登记处进行的暴露队列研究。最初被归类为“不确定”风险的治疗方法被分配更准确风险的平均时间为 27 年（95%置信区间为 26-28 年）。评估药物治疗在人类怀孕期间安全性所需的信息仍然是一个严重的公共卫生问题。需要采取更积极的方法来进行上市后监测致畸作用。
