Shahnaz Akhtar Chaudhry1, Geert't Jong1, Gideon Koren2. 1. The Motherisk Program, Division of Clinical Pharmacology & Toxicology, Department of Pediatrics, The Hospital for Sick Children, Toronto, ON, Canada. 2. The Motherisk Program, Division of Clinical Pharmacology & Toxicology, Department of Pediatrics, The Hospital for Sick Children, Toronto, ON, Canada. Electronic address: gkoren@sickkids.ca.
Abstract
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.
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.
Authors: Hulya Ozdemir; Sua Sumer; Hakan Karabagli; Gokhan Akdemir; A Zafer Caliskaner; Hasibe Artac Journal: Ann Saudi Med Date: 2018-01-09 Impact factor: 1.526
Authors: P Emanuela Voinescu; Suna Park; Li Q Chen; Zachary N Stowe; D Jeffrey Newport; James C Ritchie; Page B Pennell Journal: Neurology Date: 2018-09-05 Impact factor: 11.800