Major Birth Defects Not Linked to Newer Antiepileptic Drugs

Use of newer antiepileptic drugs in first trimester not correlated with increased birth defect risk

TUESDAY, May 17 (HealthDay News) -- Exposure to newer-generation antiepileptic drugs in the first trimester of pregnancy is not correlated with an increase in major birth defects in a Danish cohort of live-born infants, according to a study published in the May 18 issue of the Journal of the American Medical Association.

Ditte Mølgaard-Nielsen and Anders Hviid, Dr.Med.Sci. from Statens Serum Institut in Copenhagen, Denmark, assessed the correlation between fetal exposure to newer-generation antiepileptic drugs during the first trimester of pregnancy and the risk of major birth defects. Data were collected from 837,795 live-born infants in Denmark from January 1996 through September 2008. Antiepileptic drugs dispensed to mothers, birth defect diagnoses, and potential confounders were recorded. The main outcome studied was the prevalence odds ratio (POR) of any major birth defect diagnosed within the first year of life following prenatal exposure to antiepileptic drugs.

The investigators identified birth defects in 49 of the 1,532 infants who were exposed to lamotrigine, oxcarbazepine, topiramate, gabapentin, or levetiracetam in the first trimester, compared to 19,911 out of 836,263 who were not given any antiepileptic drug (3.2 versus 2.4 percent; adjusted POR, 0.99; 95 percent confidence interval 0.72 to 1.36). Major birth defects were seen in 3.7 percent of infants exposed to lamotrigine, 2.8 percent exposed to oxcarbazepine, and 4.6 percent exposed to topiramate, but the adjusted PORs were not significant. Exposure to gabapentin and levetiracetam was uncommon during the first trimester and only one (1.7 percent) and zero birth defects were reported, respectively.

"First-trimester exposure to lamotrigine, oxcarbazepine, topiramate, gabapentin, or levetiracetam compared with no exposure was not associated with an increased risk of major birth defects," the authors write.

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