Department of Obstetrics and Gynecology, Perinatal Pharmacology, Zurich University Hospital, Zurich, Switzerland.
J Perinat Med. 2013 May;41(3):301-7. doi: 10.1515/jpm-2012-0091.
To provide the first update on drug safety profiles and adverse drug reactions (ADRs) associated with fetal disorders from the Swiss national ADR database.
We conducted a retrospective study using data from 202 pharmacovigilance reports on drug-associated fetal disorders from the Swiss national ADR database from 1990 to 2009. Evaluated aspects included administrative information on the report, drug exposure, and disorders.
The ADR reporting frequency on the topic of fetal disorders has increased during the last 20 years, from only 1 report in 1991 to a maximum of 31 reports in 2008. Nervous system drugs were the most frequently reported drug group (40.2%) above all antidepressants and antiepileptics. The highest level of overall drug intake could be observed for the 1st trimester (85.4%), especially for the first 6 weeks of pregnancy. The most frequently reported types of fetal disorders were malformations (68.8%), especially those of the musculoskeletal and circulatory systems. A positive association was discovered between antiepileptics and malformations in general and in particular of the circulatory system and the eye, ear, face, and neck.
The results suggest that the nervous system drug group bears an especially high risk for malformations. The most commonly identified drug exposures can help focus pharmacoepidemiologic efforts in drug-induced birth defects.
提供来自瑞士国家不良反应数据库的与胎儿疾病相关的药物安全性概况和药物不良反应（ADR）的最新信息。
我们使用了 1990 年至 2009 年期间来自瑞士国家不良反应数据库的 202 份与药物相关的胎儿疾病不良反应报告的数据，进行了一项回顾性研究。评估的方面包括报告的管理信息、药物暴露和疾病。
在过去的 20 年中，关于胎儿疾病的不良反应报告频率有所增加，从 1991 年的仅有 1 份报告增加到 2008 年的最多 31 份报告。神经系统药物是最常报告的药物类别（40.2%），超过了所有的抗抑郁药和抗癫痫药。总体药物摄入水平最高的是孕早期（85.4%），特别是在怀孕的前 6 周。最常报告的胎儿疾病类型是畸形（68.8%），特别是肌肉骨骼和循环系统的畸形。发现抗癫痫药与一般畸形，特别是与循环系统和眼、耳、面部和颈部畸形之间存在正相关关系。
结果表明，神经系统药物组的畸形风险特别高。最常见的药物暴露可以帮助集中药物引起的出生缺陷的药物流行病学研究。
