North American Antiepileptic Drug Pregnancy Registry Study

The North American Antiepileptic Drug (AED) Pregnancy Registry was founded in 1997 as an avenue in which to study the potential risks to a fetus resulting from exposure to anti-epileptic drugs during pregnancy. Since its inception, the registry has enrolled 6,456 women taking anticonvulsant drugs while pregnant. In order to enroll, women must simply telephone the registry. They are then interviewed three separate times: once at the time of enrollment, once after seven month’s gestation, and once between eight and twelve weeks after the delivery date. This AED pregnancy registry was developed in order to systematically study the variety of birth defects associated with the use of specific anti-epileptic drugs.

Depakote During Pregnancy Research

This Neurology study was conducted for publication in the North American Antiepileptic Drug Pregnancy Registry. According to researchers, women who take valproate, the generic form of the anticonvulsant drug Depakote, during the first trimester of pregnancy have a significantly increased risk of giving birth to children with major congenital birth defects. These birth defects include microcephaly, pulmonary atresia, spina bifida, hypospadias, heart defects, and developmental delay. Even more revealing, the report indicated that the risk of severe birth defects among infants exposed to valproate in utero was significantly higher than the risk among infants born to women who took other anticonvulsant drugs during pregnancy.

In the past, experts suggested that women who take folic acid supplements before and during pregnancy could prevent up to 70% of all birth defects. Unfortunately, in this study, all sixteen of the women who gave birth to infants with major congenital malformations had taken either multivitamins with folic acid or folic acid supplements during pregnancy. In fact, researchers stated that the three infants who developed spina bifida were born to women who consumed the daily recommended amount of folic acid.

Depakote Versus Other Anti-Epileptic Drugs

The investigators involved in this report suggest that this study reasserts the findings of several previous studies. Not only are valproate and Depakote associated with serious adverse side effects in infants exposed to the drugs in utero, but these birth defects also occur more frequently among infants whose mothers took valproate, compared to infants whose mothers took any other anti-epileptic drug. Furthermore, even infants born to women who take the appropriate amounts of folic acid, which was believed to help prevent birth defects in the past, have a significantly higher risk of developing major birth defects when exposed to anticonvulsant drugs like valproate in utero.

Depakote Related Journal Quotes

“The risk for women taking [valproate] VPA of having a baby with a [neural tube defect] NTD is about 2 to 5%. Thus, in our sample of 149 VPA-exposed women, two to eight infants with NTD would be expected and three were observed.”

“One notable and new finding in our study was the occurrence in two infants of pulmonary atresia, a severe heart defect. The suggested increased frequency of craniosynostosis, especially metopic synostosis, was validated.”

“There was a fourfold increased risk for having an offspring with a major birth defect for VPA-exposed women compared with those taking other AEDs.”

“Every anticonvulsant drug studied in human pregnancies, to date, including phenobarbital, phenytoin, carbamazepine, and valproate, has been shown to be teratogenic,” which is defined as the potential for a drug to cause fetal malformation.

Depakote Study Links

http://www2.massgeneral.org/aed/articles/Neurology2005.pdf

http://www2.massgeneral.org/aed/index.htm

http://www2.massgeneral.org/aed/articles/Neurology2008.pdf

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