Evolving Knowledge of the Teratogenicity of Medications in Human Pregnancy
Evolving Knowledge of the Teratogenicity of Medications in Human Pregnancy
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DOI：
10.1002/ajmg.c.30313
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发表时间：
2011-08-15
影响因子：
3.1
通讯作者：
Friedman, J. M.
中科院分区：
文献类型：
--
作者：
Adam, Margaret P.;Polifka, Janine E.;Friedman, J. M.
大多数孕妇在怀孕期间至少服用一种药物，尽管这些药物在怀孕期间的安全性并不总是已知的。我们使用TERIS风险评级系统对2000年至2010年美国食品和药物管理局（FDA）批准的172种药物在妊娠期间的安全性进行了审查。我们还审查了1980年至2000年FDA批准的468种药物的安全性信息，以确定在过去10年中是否对风险类别进行了修订。在2000年至2010年期间批准的168种（97.7%）药物治疗中，人类妊娠的致畸风险“未确定”。此外，126种药物（73.3%）关于妊娠安全性的可用数据量被评为“无”。在1980年至2000年期间批准的药物中，只有23种（5%）在过去10年中改变了完整的风险类别或更多。导致修订风险的数据来源来自通过记录关联研究、致畸剂信息服务、基于大人群的病例对照研究和妊娠登记进行的暴露队列研究。最初被归类为“不确定”风险的治疗到指定更精确风险的平均时间为27年（95%置信区间26-28年）。缺乏评估人类怀孕期间药物治疗安全性所需的信息仍然是一个严重的公共卫生问题。有必要采取更积极的方法对致畸作用进行上市后监测。(C)2011 Wiley-Liss，Inc.
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. (C) 2011 Wiley-Liss, Inc.