Depakote Associated with Higher Risk of Birth Defects

Gainsesville, FLWhen it comes to choosing whether or not to take Depakote, many patients and doctors examine whether the risk of Depakote birth defects is worth the benefits, and in many cases it is. After all, the medication is designed to prevent seizures, which can have serious consequences for pregnant women. But when there are other drugs that could potentially help women, without the risk of Depakote side effects, then is the drug actually worth the risk?

Research undertaken by the Neurodevelopmental Effects of Antiepileptic Drugs study group (and published in the journal Neurology; 8/8/06) suggests that Depakote should be the last resort for pregnant women with epilepsy. According to researchers, when compared with other antiepileptic drugs, Depakote was associated with significantly more major congenital malformations and fetal deaths. Furthermore, researchers found, the effects were dose dependent.

For the study, Depakote was compared with Lamictal, Tegretol and Dilantin. "These results combined with several recent studies provide strong evidence that valproate [the generic name for Depakote] poses the highest risk to the fetus," researchers wrote. "For women who fail other antiepileptic drugs and require valproate, the dose should be limited if possible."

Researchers found 12 serious birth defects in the group of women who took Depakote while pregnant, including coarctation of the aorta, hypoplastic right heart, atrial septal defects, cleft palate and pulmonary stenosis. The study led researchers to conclude that women should be given antiepileptic medications other than Depakote where possible and, where not possible, be given the lowest possible dose while still deriving benefits from taking the medication.

In 2009, the US Food and Drug Administration (FDA) issued a warning about the risks associated with Depakote, including the increased risk of neural tube defects and other major birth defects. At the time, the FDA noted that women of childbearing potential should only use valproate if it is essential to manage their medical condition, while women who take Depakote but are not planning on getting pregnant should use effective contraception. FDA noted that women who take Depakote for migraines or other non-life threatening conditions should consider alternative therapies.

On June 30, 2011, the FDA further warned that children exposed to Depakote in utero were at an increased risk for lower cognitive test scores.