title: The fetal safety of Levetiracetam: a systematic review.
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.
authors.affiliation: The Motherisk Program, Division of Clinical Pharmacology & Toxicology, Department of Pediatrics, The Hospital for Sick Children, Toronto, ON, Canada.
authors.forename: Shahnaz Akhtar
authors.initials: SA
authors.lastname: Chaudhry
authors.affiliation: The Motherisk Program, Division of Clinical Pharmacology & Toxicology, Department of Pediatrics, The Hospital for Sick Children, Toronto, ON, Canada.
authors.forename: Geert't
authors.initials: G
authors.lastname: Jong
authors.affiliation: The Motherisk Program, Division of Clinical Pharmacology & Toxicology, Department of Pediatrics, The Hospital for Sick Children, Toronto, ON, Canada. Electronic address: gkoren@sickkids.ca.
authors.forename: Gideon
authors.initials: G
authors.lastname: Koren
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology; D000818:Animals; D000927:Anticonvulsants / Q000633:toxicity*; D005260:Female; D005315:Fetal Diseases / Q000139:chemically induced* / Q000473:pathology; D005333:Fetus / Q000473:pathology; D006801:Humans; D000077287:Levetiracetam; D010889:Piracetam / Q000031:analogs & derivatives* / Q000633:toxicity; D011247:Pregnancy; D011297:Prenatal Exposure Delayed Effects / Q000139:chemically induced; D012449:Safety
chemical_list: D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam
keywords: Adverse outcome; Birth defects; Levetiracetam; Pregnancy; Safety