Depakote® Studies

Depakote® is an FDA approved drug manufactured by Abbott Laboratories, comprised of sodium valproate and valproic acid. It has been marketed and prescribed as treatment for epilepsy, bi-polar mania, and migraines.  Unfortunately, key studies have shown that women who take Depakote® during pregnancy are more likely to have children born with serious birth defects.

The Neurodevelopmental Effects of Antiepileptic Drugs

A study done by the Department of Neurology at the Medical Department of Georgia explored the connection between the use of antiepileptic drugs such as Depakote® and birth defects. This study, titled "The Neurodevelopmental Effects of Antiepileptic Drugs" (NEAD) reported that Depakote® should be "at the bottom of the list" when prescribing antiepileptic drugs for pregnant women with epilepsy. The study explained:

“The Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study is a prospective, multicenter study in the United Kingdom and United States, which has enrolled more than 300 mothers with epilepsy during their pregnancies in order to determine the long-term neurobehavioral development effects of in utero AED monotherapy exposure to the four commonly used AEDs (carbamazepine, lamotrigine, phenytoin, and valproate). A preliminary analysis of serious adverse fetal outcomes (i.e., fetal death, major congenital malformation, or developmental delay) revealed significant differences across AEDs. Serious adverse outcomes occurred in 10% of carbamazepine [Tegretol], 2% of lamotrigine [Lamictal], 12% of phenytoin [Dilantin], and 24% of valproate [Depakote] children.  Thus, several different investigations of children exposed in utero to valproate have found worse outcomes for valproate even though the investigations evaluated seven different cohorts from around the world, employed different methodologies, and even had different outcome measures.  The pregnancy registries and the NEAD study are ongoing, and statistical differentiation of the AEDs for the pregnancy registries is not complete. However, the likelihood of all seven studies consistently finding a worse outcome for valproate by chance is statistically unlikely. Taken together, these studies raise serious concerns over the use of valproate as a first-line AED in women of childbearing potential.”

According to the study, there were serious adverse events in the Depakote® group, including spina bifida, craniosynostosis, brachycephaly, coarctation of the aorta, hypoplastic right heart, atrial septal defects, hydronephrosis, undescended testes, hypospadias, cleft palate, dysplastic ribs, hand malformations, and pulmonary stenosis.

Of the four anticonvulsant drugs used in the study, Depakote® posed the highest risk for birth defects. Of all birth defects mentioned, spina bifida had the highest occurrence, followed by craniosynostosis (premature closing of bones of the skull) and cleft palate syndrome.

North American AED Pregnancy Registry

The North American AED (Antiepileptic Drug) Pregnancy Registry at the Massachusetts General Hospital reported that women taking valproate drugs, such as Depakote®, are more likely to have children born with birth defects, compared to women taking other anticonvulsants.

The study done by the North American AED Pregnancy Registry included many women who took the anticonvulsant drug during pregnancy over a 6 year period. This study determined the risk level for birth defects of women taking valproate drugs such as Depakote® during pregnancy was substantially higher than for other anticonvulsants.

New England Journal of Medicine Study

Another study, led by the University of Groningen in the Netherlands and published in the New England Journal of Medicine, found that children of mothers who took  valproic acid during the first trimester were substantially more likely to have spina bifida than those born of mothers who did not.

The study also found that children of mothers who took these drugs were more likely to have a heart defect, more likely to have a cleft palate or hypospadias, more likely to be born with an extra digit, and more likely to have craniosynostosis.

The Netherlands study concluded that the birth defects were not caused by the epilepsy, but by the antiepileptic drug taken for the disorder. After considering the risk between valproic acid use and birth malformations, these researchers urge women who are considering getting pregnant or are already pregnant to look towards other drugs to control their epileptic seizures.

Regain Your Child’s Future

If you were pregnant while taking Depakote®, you may be entitled to financial compensation that can help alleviate medical bills and ease your family's pain. Our extensive resources and pharmaceutical litigation expertise is at your side during this difficult time. Call (800) 800-3189 for a free consultation with our knowledgeable lawyers.

Schedule an appointment with your doctor to fully evaluate your child's condition. Please ask the physician to document the diagnosis, prognosis, and if possible, the expected costs associated with the treatment the child will need throughout his or her life. This information will help our lawyers determine the strength of your case as we evaluate your legal options.

Do not delay. The statute of limitations in your state may prevent you from filing a lawsuit at a later date. Our lawyers will provide you with all of the information you need to make an informed decision about your child's future.