Abstracts

Rationale: The UCB Antiepileptic Drug Pregnancy Registry was created to advance scientific knowledge about safety and outcomes associated with use of UCB AEDs in pregnancy. Methods: Enrollment in the US-based, observational, exposure-registration, prospective, follow-up registry is voluntary. The prevalence of birth defects is compared to prevalence in the Metropolitan Atlanta Congenital Defects Program, a population-based birth defects surveillance system administered by the Centers for Disease Control and Prevention. NCT00345475 Results: As of 28FEB2010, 428 women taking Keppra (n=415), Keppra XR (n=8) or both (n=5), were prospectively enrolled in the registry. Pregnancy outcomes were known for 385 women (387 fetal exposures), including 365 live births (two twin pregnancies), one induced abortion, three fetal deaths, and 18 spontaneous pregnancy losses. Total exposure data included 351, 30, and 6 first, second, and third trimester exposures, respectively. Birth defects were reported in 26 of 365 live births and in 1 fetal death. Defects were reported in 12/253 (4.7%) live births following Keppra/Keppra XR monotherapy, including first trimester (10/227 exposed live births): peripheral pulmonary artery stenosis/patent foramen ovale, subaortic ventricular septal defect, bilateral club feet, pulmonary stenosis/dysplastic pulmonary valve, positional plagiocephaly/intermittent esophoria/flat feet, cleft lip, congenital torticollis/hydroceles, polydactyly/hemangioma, pyloric stenosis, and macrocephaly; second trimester (1/21 exposed live births): congenital nystagmus/scalp hemangioma; third trimester (1/5 exposed live births): congenital nevus/achrochordon/nevus simplex. Defects were reported in 13/105 (12.4%) live births following Keppra/Keppra XR polytherapy without valproate, including first trimester (12/95 exposed lived births): congenital adrenal hyperplasia/Chiari I malformation ( phenytoin), facial asymmetry/hypertelorism/natal tooth/wide anterior fontanelle/hemangioma ( phenobarbital), ventricular septal defect/genu valgum ( oxcarbazepine and clonazepam), cleft palate/left eye ptosis ( carbamazepine), ectopic right kidney ( carbamazepine and phenytoin), membranous ventricular septal defect/atrial septal defect, hydronephrosis/posterior urethral valve, hypospadias, capillary hemangioma, hemangioma/right temporal dermoid cyst, omphalocele, 4th toe crosses under 3rd toe/hemangioma lower back ( lamotrigine for all); second trimester (1/9 exposed live births): hypopigmentation fingers ( lamotrigine); third trimester (0/1 exposed live birth). One case of hemangiomas was reported out of 7 live births following polytherapy with valproate (all first trimester exposures). Finally, bilobed right lung/small mouth was identified in a stillbirth with first trimester exposure to Keppra and phenytoin. Conclusions: The Expert Panel concluded that the limited amount of data currently available were insufficient to draw conclusions. The number of ventricular septal defects remains unchanged from the previous four reports. The Panel will update their assessment as more data become available.