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Antiepileptic Drugs and Pregnancy: Registry Data
An international consortium reviews the evidence on risks for malformations and recommends future research directions.
This consensus statement stemmed from the Health Outcomes in Pregnancy and Epilepsy (HOPE) forum, an international conference organized to summarize current information on issues regarding pregnancy in women with epilepsy (WWE) and identify areas for future research.
The major established pregnancy registries include the European and International Registry of Antiepileptic Drugs in Pregnancy (EURAP) and the North American (NA), United Kingdom (U.K.), and Australian registries. The registries have shown slightly different risks for malformations with specific antiepileptic drugs (AEDs), probably because of differences in patient populations and recruitment. Despite these differences, valproate, whether as monotherapy or polytherapy, is consistently associated with the highest rate of malformations, and this risk might be dose-dependent. Malformation rates overall have been slightly higher in the EURAP, U.K., and Australian registries compared with the NA registry. The last is the only registry to document increased rates of cleft lip or palate in offspring of lamotrigine and carbamazepine users. Lower IQ scores have been seen in offspring of WWE on valproate and phenobarbital, compared with controls. Little information exists on the association of levels of AEDs in breast milk with cognitive outcomes. The authors suggest that future research focus on specific malformations and on confounders of outcomes such as epilepsy type and AED serum levels.
Comment: This comprehensive article reviews important literature on antiepileptic drug use in women with epilepsy. Despite limitations and variable results of the registries, the data support avoiding valproate in WWE of reproductive age because it increases the risk for malformations and lowered IQ in their offspring. Cognitive effects of AED exposure and AED levels in breast milk will require more-extensive research.
— Autumn Klein, MD, PhD
Dr. Klein is Instructor in Neurology and Director, Program in Women’s Neurology, Harvard Medical School and Brigham and Women’s Hospital, Boston.
Published in Journal Watch Neurology January 6, 2009
Citation(s):
Meador KJ et al. Pregnancy registries in epilepsy: A consensus statement on health outcomes. Neurology 2008 Sep 30; 71:1109.
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