EUROmediCAT Recommendations for European Pharmacovigilance concerning safety of medication use in pregnancy.
EUROmediCAT Recommendations for European Pharmacovigilance concerning safety of medication use in pregnancy.
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DOI：
10.1002/pds.3866
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发表时间：
2015-10-01
影响因子：
2.6
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中科院分区：
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本文件列出了EUROmediCAT项目对欧洲和国家药品监管机构、公共卫生机构和专业临床机构的建议·旨在改善未来的药物警戒·为未来的药物安全措施提供信息这些建议旨在帮助更好地利用欧洲的现有数据、网络和基础设施，建立一个更完整的系统，更好地传播知识，提高生殖药物警戒水平，以满足妇女的合理期望。这些建议特别集中在与先天性异常风险有关的怀孕早期安全问题上。对于其他不良妊娠结局（如流产、早产或宫内发育迟缓），特别是妊娠期药物暴露的神经行为影响，以及疾病/病症本身对妊娠结局的影响，也应采取更广泛的观点，
PURPOSEThis paper sets out the Recommendations from the EUROmediCAT project for European and national medicines regulatory agencies, public health authorities and professional clinical bodies• To improve future pharmacovigilance• To inform future drug safety measuresThe recommendations are designed to help make better use of current data, networks and infrastructures in Europe, to achieve a more integrated system and better dissemination of knowledge and to raise the level of reproductive pharmacovigilance to meet women’s reasonable expectations. These recommendations concentrate particularly on safety in early pregnancy in relation to the risk of congenital anomalies. Wider perspectives should also be taken with respect to other adverse pregnancy outcomes (such as miscarriages, preterm birth or intrauterine growth retardation) and particularly neurobehavioural effects of medication exposure in pregnancy, with respect to the effects of the diseases/conditions themselves on pregnancy outcome, with