Studies: Risks of Congenital Defects Increased in Users of Depakote

Santa Fe, NMFor women dealing with epileptic seizures, the risk of Depakote side effects might not seem like much of a concern. But, if they are taking the epilepsy drug for migraines and are told the reported side effects could include a risk of Depakote birth defects, their concern might increase. Among the reported birth defects associated with Depakote are an increased risk of spina bifida, atrial septal defect and, according to at least one study, lowered I.Q.

The I.Q. study, published in 2009 in The New England Journal of Medicine, found that children who were exposed to Depakote prior to birth had I.Q. scores that were significantly lower than children exposed to a different antiseizure medication. The New York Times (04/15/09) reports that three year olds who were exposed to valproate—the generic version of Depakote—prior to birth had I.Q. scores nine points lower than three year olds who were exposed to lamotrigine, a different antiseizure medication.

Researchers further determined that for most infants, the I.Q. score was strongly linked to the mothers' I.Q. scores, except when it came to the children exposed to valproate. They concluded, "In utero exposure to valproate was associated with poorer cognitive outcomes than was exposure to other commonly used antiepileptic drugs." Furthermore, the effect of valproate on the child's I.Q. was dose dependant. Researchers noted that their findings were consistent with studies in the United Kingdom.

Finally, researchers noted that several studies have shown an increased risk of congenital malformations compared with other antiepileptic medications. This was further confirmed in a different study that appeared in The New England Journal of Medicine (06/10/10), which noted that "The use of valproic acid in the first trimester of pregnancy is associated with an increased risk of spina bifida." Researchers went on to note that data on the risks associated with other birth defects is limited, which is why they undertook their study.

For the study, researchers combined the data from other studies to determine the risks of other birth defects associated with the use of valproic acid. They found that the use of valproic acid was associated with "significantly increased risks of several congenital malformations," even when compared with the use of other antiepileptic medications. Among the birth defects found to be associated with valproic acid were spina bifida, atrial spetal defect, cleft palate and craniosynostosis