Abstracts

Antiepileptic drugs (AED) have been reported to increase the risk of congenital malformations (CM) in the offspring of mothers who use these drugs. Since there is a significant risk of seizures for the mother during pregnancy, it may be necessary for the mother to continue taking AEDs throughout her pregnancy., We performed a systematic literature review to identify all published registries and cohort studies of [ge] 1000 births from pregnant epileptic women that reported an incidence of a major congenital malformation., The review included 6 studies (k) that met the inclusion criteria with a total of 16,095 births to epileptic mothers. Three studies reported the incidence of births with CM, three studies reported the incidence of CM as total events, and 4 studies reported the incidence of specific major congenital malformations. The incidence of births with CM was 5.2% (k=3), and the incidence of CM (as events) was 4.5% (k=3). The incidence of spina bifida was 0.2% (k=3), cardiovascular CMs was 0.9% (k=2), cleft lip or palate was 0.3% (k=2), urinary malformations was 0.5% (k=3), and club foot was 0.7% (k=1). There were three studies that separately reported monotherapy, polytherapy, and/or non-treated epileptic pregnancies. The incidence of births with CM in women treated with only 1 AED was 6.2% (k=2), for polytherapy it was 10.2% (k=2), and for no AED treatment it was 2.8% (k=1). The incidence of CM events was 3.9% (k=2) for monotherapy, 6.3% (k=2) for polytherapy, and 3.2% (k=2) for no AED treatment., The results of this systematic literature review suggest that the incidence of congenital malformations in the offspring of epileptic mothers is approximately 4% to 5%. The risk of congenital malformations increases from no AED treatment (approximately 3%) to treatment with a single AED (from 4% to 6%), and is highest when the mothers are treated with multiple AEDs (6% to 10%)., (Supported by Shire Development Inc.)