期刊
REPRODUCTIVE TOXICOLOGY
卷 46, 期 -, 页码 40-45出版社
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/j.reprotox.2014.02.004
关键词
Pregnancy; Levetiracetam; Safety; Adverse outcome; Birth defects
资金
- Ivey Chair in Molecular Toxicology, at Western University
- Research Leadership for Better Pharmacotherapy during Pregnancy and Lactation, at Sick kids Hospital
Objective: To systematically review the available published evidence on the fetal safety of Levetiracetam with focus on birth defects. Results: Eight studies met the inclusion criteria; five pregnancy registries and one population based cohort study. A total of 27 major congenital malformations were reported among 1213 Levetiracetam monotherapy - exposed pregnant women, yielding an overall major malformation rate of 2.2% (27/1213) [95% confidence interval of 1.53-3.22]. In contrast, Levetiracetam polytherapy was associated with significantly higher malformation rate of 6.3% (34/541) [95% CI of 4.53-8.65] (P < 0.001). Additionally 2 studies investigating child neurodevelopment in Levetiracetam - exposed children revealed that the measured achievements were well above those children exposed to valproic acid, and similar to unexposed controls. Conclusions: The current evidence suggests that the overall risk of major malformation after first trimester exposure to Levetiracetam is within the population baseline risk of 1-3%, with no apparent adverse effects on long term child development. (C) 2014 Published by Elsevier Inc.
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