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The fetal safety of Levetiracetam: a systematic review
Shahnaz Akhtar Chaudhry1, Geert't Jong1, Gideon Koren1
1The Motherisk Program, Division of Clinical Pharmacology & Toxicology, Department of Pediatrics, The Hospital for Sick Children, Toronto, ON, Canada.
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.
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