The study also found that the effects of Depakote were dependant on the dose taken. The study compared women who took Depakote while pregnant with women who took Lamictal, Tegretol, and Dilantin.
Of the women who took Depakote while pregnant, 20.3% had babies who experienced serious adverse outcomes. This is compared with 10.7% of those taking Dilantin, 8.2% on Tegretol, and 1.0% on Lamictal. The serious adverse events in babies who were exposed to Depakote included coarctation of the aorta, atrial septal defects, hydronephrosis (distention and dilation of the renal pelvis), cleft palate, dysplastic ribs, pulmonary stenosis, hand malformations, undescended testes, hypospadias (a birth defect in males that involves the urethral opening occurring in the wrong place), and hypoplastic right heart.
Women who took a high dose of Depakote had a higher likelihood of giving birth to a baby with defects. Those who were at or above the average first trimester dose had adverse outcomes at a rate of 24.2% whereas those who had doses below the average had adverse outcomes at a rate of 9.1%
According to a warning at rxlist.com, antiepileptic drugs should only be given to women of childbearing potential if they are absolutely essential in the management of seizures. The same warning says that the risks of neural tube defects may be higher in mothers who received Depakote during the first trimester of pregnancy. Hepatic failure which resulted in the deaths of newborns and infants were also reported after the mothers took Depakote while pregnant. Depakote has also been linked to birth defects such as poor growth, developmental delays, short and broad noses, small teeth and small head.
Additionally, the risk of having a child born with spina bifida is approximately one to two percent when the fetus was exposed to Depakote, whereas in the general population, spina bifida occurs in fewer than one in one thousand births. Unfortunately, spina bifida develops during the fourth week of pregnancy at which point many women do not even realize that they are pregnant. Spina bifida is a birth defect in which the spinal column fails to completely close which results in a lesion on the newborn's back and a loss of feeling from the lesion down.
Animal studies have shown that exposure to Depakote before birth increases the likelihood of malformations, intrauterine growth retardation and death of the newborn. Malformations included skeletal system defects and neural tube closure defects.
Depakote is known generically as divalproex sodium and is prescribed to treat seizures. It is a compound of sodium valproate and valproic acid and is therefore sometimes referred to as valproate. It works by affecting chemicals in the body that may cause seizures. Depakote was also approved by the U.S. Food and Drug Administration (FDA) in 1995 for the short-term treatment of bipolar disorder.
Depakote is FDA pregnancy category D because it can harm an unborn baby. Women who are pregnant or planning on becoming pregnant should speak with their doctors to discuss their options because Depakote has been linked to birth defects. Depakote can also pass into breast milk and harm a nursing baby.