Antiepileptic Drugs and Birth Defects

Andrew N. Wilner, MD


August 31, 2011

In This Article

Antiepileptic Drugs and Teratogenicity

A recently published epidemiologic study suggests that prenatal exposure to any of 5 new antiepileptic drugs (AEDs) in the first trimester of pregnancy is not associated with major congenital malformations.[1] This population-based cohort study compared the incidence of major congenital anomalies among 1532 infants exposed to gabapentin, lamotrigine, levetiracetam, oxcarbazepine, or topiramate during the first trimester with the incidence of major anomalies in 836,263 control infants. Data came from the Danish Medical Birth Registry and included all Danish births from January 1, 1996, through September 30, 2008.

Major Congenital Malformations

The study included women who took antiepileptic drugs for epilepsy (N = 1164), migraine (N = 34), mood disorders (N = 28) and other conditions. Of the 1532 infants exposed to one of the new AEDs during the first trimester, 49 had a major birth defect (3.2%). Of the 836,263 controls, 19,911 had a major birth defect (2.4%). After correction for confounding factors such as concomitant use of older-generation AEDs and the maternal diagnosis of epilepsy, these differences were not statistically significant.

Major congenital anomalies were defined in accordance with the European Surveillance of Congenital Anomalies (EUROCAT) registry and included abnormalities such as anophthalmos, bilateral renal agenesis, congenital heart disease, limb reduction, neural tube defects, oral-facial clefts, and many others.[2] Minor abnormalities[3] were not included. Infants with chromosomal aberrations, genetic disorders, birth defects with known causes such as the fetal alcohol syndrome, or aborted fetuses were also excluded.


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