Felix Robert J, Jones Kenneth Lyons, Johnson Kathleen A, McCloskey Carolyn A, Chambers Christina D
California Teratogen Information Service and Clinical Research Program, Department of Pediatrics, University of California San Diego, La Jolla, CA 92103, USA.
Birth Defects Res A Clin Mol Teratol. 2004 Dec;70(12):944-7. doi: 10.1002/bdra.20090.
Although medications are frequently used during pregnancy, premarketing studies exclude pregnant women, with the result that maternal and fetal risks of medications are largely unknown prior to marketing.
To demonstrate the feasibility of using Teratology Information Services (TISs) to identify potential subjects who may participate in postmarketing surveillance studies regarding medications taken during pregnancy, maternal characteristics and pregnancy exposure data routinely collected from callers to member agencies of the Organization of Teratology Information Services (OTIS) were pooled for two one-month periods.
A total of 3536 calls inquiring about 7746 different agents were received from pregnant women. Of the 40 medications about which pregnant women most frequently asked, the top two were nonprescription acetaminophen and pseudoephedrine, three were prescription drugs with a U.S. Food and Drug Administration pregnancy label category D designation, and five were prescription antidepressants.
TISs are well positioned to prospectively ascertain medication exposures in large numbers of pregnant women and may be an exceptional resource for conducting postmarketing surveillance for the safety of medications taken during pregnancy.
尽管孕期经常使用药物，但上市前研究将孕妇排除在外，结果导致药物对母婴的风险在上市前很大程度上未知。
为证明利用致畸信息服务（TIS）来识别可能参与孕期用药上市后监测研究的潜在受试者的可行性，将从致畸信息服务组织（OTIS）成员机构的来电者中常规收集的母亲特征和孕期暴露数据汇总了两个为期一个月的时间段。
共收到孕妇打来的3536个咨询7746种不同药物的电话。在孕妇最常询问的40种药物中，前两种是非处方对乙酰氨基酚和伪麻黄碱，三种是美国食品药品监督管理局妊娠标签分类为D类的处方药，还有五种是处方抗抑郁药。
致畸信息服务有很好的条件前瞻性地确定大量孕妇的药物暴露情况，可能是开展孕期用药安全性上市后监测的绝佳资源。
