Results Of A Multicentered Registry Of Oxcarbazepine Exposed Pregnancies
Abstract number :
3.206;
Submission category :
7. Antiepileptic Drugs
Year :
2007
Submission ID :
7952
Source :
www.aesnet.org
Presentation date :
11/30/2007 12:00:00 AM
Published date :
Nov 29, 2007, 06:00 AM
Authors :
P. E. Penovich1, 2, J. Rogin3, 2, G. Montouris4, P. Pennell5, W. Rosenfeld6, V. Sosa7
Rationale: Women with epilepsy (WWE) who are of child bearing age potential face the difficult decision of either taking an AED with potential teratogenic effects or risking increased seizures which may threaten the pregnancy if no or lesser amounts of AED are taken. Experience with the newer AEDs is accumulating. Oxcarbazepine was first released in 1990 in Denmark and 2000 in USA. Exposures continue with unclear information regarding safety for the fetus. The present registry information reports the experience to date with OXC in our centers.Methods: Over 20 epilepsy programs in the USA were asked to participate. Six centers participated. Each mother signed informed consent before completing a survey with the local investigator. Data was sent to 1 site for analysis and included maternal health and reproductive history; seizure history; AED use and seizure occurrence during the pregnancy; folate and prenatal vitamin use; ultrasound results; complications during the pregnancy; apgar scores and delivery complications; gestational age; infant malformations; breastfeeding.Results: Six centers provided data for a total of 29 pregnancies: 27 retrospective and 2 prospective with 1 of these yet to deliver. Mothers were 19-38 years old (mean age =26.7) with epilepsy onset from 0.25-31 years of age. Mean OXC doses increased through trimesters from a mean daily dose at conception of 1295mg/day→1495→1725→1840 mg/day at delivery. 55% were on monotherapy. Two patients (7%) were seizure free throughout; 6 had only simple partial ± complex partial seizures; 1 had status epilepticus. 50% of all patients who had seizures had seizures in 1st and 2nd trimesters, 38% in 3rd, and 8% at delivery. Ultrasounds were abnormal in 4 (1 oligohydramnios, 2 polyhydramnios, 1 small for gestational age). 73% delivered vaginally. There were 2 fetal losses and 1 preterm delivery. Apgars were >7 and 9 in all reported. Hypospadius was the only malformation reported,occurring in an infant exposed to monotherapy. 93% received folate (mean dose 2.4 mg) and prenatal vitamins. Maternal complications reported were 2 hyperemesis, 1 preeclampsia, 1 bed rest, 1 elevated GTT, 1 fall, 1 1st trimester bleeding, 1 depression. 62.5% reported breastfeeding. Reported data was insufficient to assess infant development.Conclusions: Collection of experience with OXC during pregnancy is still limited. Malformation rates appear to be comparable to reported rates for pregnancies in WWE with other AEDs or without therapy. In this multi-centered experience additional pregnancies support the statement that mothers taking OXC during pregnancy have successful outcomes with AED mono or polytherapy.
Antiepileptic Drugs