Abstracts

Rationale: In order to advance scientific knowledge about safety and outcomes associated with pregnant women being treated with Keppra® (levetiracetam), UCB, Inc. established the Keppra® Pregnancy Registry in January 2005. In July 2008, the registry was revised to include other UCB AEDs and is now known as the UCB Antiepileptic Drug Pregnancy Registry. 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. Although the registry is prospective, data from retrospective reports with a known outcome at the time of reporting are also reviewed. Results: As of February 28, 2009, there were 382 prospective enrollments of women taking Keppra® and 2 prospective enrollments of women taking Keppra XR® with 309 known outcomes. There were 295 live births (one twin pregnancy) 1 induced abortion, 1 fetal death, and 13 spontaneous pregnancy losses. Total exposure data (N=310) includes 277, 28 and 5 having first, second and third trimester exposures to levetiracetam, respectively. Birth defects were reported in 18 prospective cases. Defect cases following first trimester levetiracetam monotherapy (8/187) were peripheral pulmonary artery stenosis + patent foramen ovale, subaortic ventricular septal defect, bilateral club feet, pulmonary stenosis + dysplastic pulmonary valve, positional plagiocephaly, cleft lip, congenital torticollis, and polydactyly. One defect case following third trimester levetiracetam monotherapy was congenital nevus + achrochordon + nevus simplex. Defect cases following first trimester levetiracetam polytherapy (9/90) were congenital adrenal hyperplasia + Chiari I malformation (with concomitant phenytoin), facial asymmetry + hypertelorism (+phenobarbital), ventricular septal defect + genu valgum (+oxcarbazepine and clonazepam), cleft palate (+carbamazepine), membranous ventricular septal defect + atrial septal defect (+lamotrigine), hemangiomas (+valproate), ectopic right kidney (+carbamazepine and phenytoin), hydronephrosis (+lamotrigine) and hypospadias (+lamotrigine). Conclusions: The Expert Panel concluded that the limited amount of data currently available is insufficient to draw conclusions. There were no additional reports of ventricular septal defects in the most recent analysis period. The Panel will update their consensus as more data become available.