The Open Drug Safety Journal

2011, 2 : 9-20
Published online 2011 January 28. DOI: 10.2174/1876818001102010009
Publisher ID: TODSJ-2-9

RESEARCH ARTICLE
 Critical Evaluation of Antiepileptic Drugs in Epileptic Pregnant Women - Hungarian Experiences

Andrew E Czeizel, * and Ferenc Bánhidy
Foundation for the Community Control of Hereditary Diseases, Budapest, Hungary (A. E. C) Second Department of Obstetrics and Gynecology, Semmelweis University, School of Medicine, Budapest, Hungary (F. B)

* Address correspondence to this author at the 1026. Budapest, Törökvész lejtő 32, Hungary; Tel/Fax: 361 3944 712; E-mail: czeizel@interware.hu

ABSTRACT

The prevalence of epilepsy is 0.3-0.6% in pregnant women and the higher rate of structural birth defects, i.e. congenital abnormalities (CAs) was recognized in their children. There are four aims of this review based on the population-based large data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA), 1980-1996 with the good validity of CA-diagnoses. (I) Most studies on the teratogenic/fetotoxic effects of antiepileptic drugs (AED) had too small samples therefore underpowered, thus the evaluation the findings of different studies together are appropriate to draw significant conclusions, therefore the data of HCCSCA are presented here. Of 22,843 cases with CA, 95 (0.42%), while of 38,151 controls without CA, 90 (0.24 %) had mothers with medically recorded epilepsy (OR with 95% CI: 1.8, 1.3-2.4) and AED in the prenatal maternity logbook. (II) Hungary had different spectrum of AED as in Western countries, thus the teratogenic potential of some less-known AED (e.g. sultiame) can be evaluated. (III) The efficacy of recent special medical care of epileptic pregnant women introduced in 1990 is worth checking. There was no significant increase in the proportion of monotherapy but the rate of total CAs decreased by 20% in the 1990s compared to the 1980s. (IV) Folic acid may reduce the teratogenic potential of some AED, nevertheless this analysis revealed that folic acid was used less frequently by epileptic pregnant women than by non-epileptic pregnant women. Thus an international consensus statement is an urgent task in this topic.

Keywords:

Epilepsy, antiepileptic drugs, pregnancy, congenital abnormalities, phenytoin, carbamazepine, valproate, primidone, sultiame, diazepam, phenobarbital.