2011
DOI: 10.1001/jama.2011.624
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Newer-Generation Antiepileptic Drugs and the Risk of Major Birth Defects

Abstract: Among live-born infants in Denmark, 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.

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Cited by 210 publications
(97 citation statements)
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“…Observational studies investigating the association between lamotrigine exposure during pregnancy and risk for congenital malformations have yielded conflicting results thus far [21][22][23][24]. Furthermore, some of the studies were based on different types of pregnancy registries with voluntary enrollment, which often lacked the power to demonstrate statistical significance and repeatedly lacked valid comparison groups.…”
Section: Introductionmentioning
confidence: 99%
“…Observational studies investigating the association between lamotrigine exposure during pregnancy and risk for congenital malformations have yielded conflicting results thus far [21][22][23][24]. Furthermore, some of the studies were based on different types of pregnancy registries with voluntary enrollment, which often lacked the power to demonstrate statistical significance and repeatedly lacked valid comparison groups.…”
Section: Introductionmentioning
confidence: 99%
“…Molgaard-Nielsen et al [25]: one MCM (congenital heart disease) among 59 monotherapy exposures. 75% of cohort had epilepsy.…”
Section: Resultsmentioning
confidence: 99%
“…With the larger population exposed to the drug in mono-and polytherapy, statistically significant associations emerged, and the association in relation to hypospadias appeared to be dose-related. Some previous studies have failed to find statistically significant evidence of TPM teratogenesis overall (14,15). Hunt et al (16), in an analysis of the UK Pregnancy Register data, also found statistically significant evidence that TPM exposure was associated with increased fetal malformation rates, but their rates for oral clefts (2.2%) did not quite reach a P < 0.05 value [a point brought out by Fountain (17)].…”
Section: Discussionmentioning
confidence: 98%