Generic: Valproic Acid
Approved to treat: Seizures
Drug category: Anticonvulsant
Year approved: 1983
Manufacturer: Abbott Laboratories
Babies who are prenatally (before birth) exposed to Depakote have an increased risk of developing birth defects, including:
- Cleft Palate – 4 times increased risk
- Atrial Septal Defects (holes in the heart wall)
- Polydactyly (hand or foot malformation) – 4 times increased risk
- Dysplastic or abnormally developed ribs
- Hypospadias (condition in male babies that causes the opening of the urethra to occur at the wrong place)
- Spina Bifida (condition that results in the spinal column failing to completely enclose the spinal cord) – 10 times increased risk
- Craniosynostosis – 4 times increased risk
Multiple Studies Find Link Between Valproic Acid Use and Birth Defects
There have been several studies over the years that have indicated an association between prenatal exposure to Depakote and serious or even life threatening birth defects. According to a June 2010 study published in the New England Journal of Medicine, babies whose mothers took Depakote during pregnancy are more than 12 times more likely to be born with spina bifida, compared to unexposed babies.
Also, the North American Antiepileptic Drug Pregnancy Registry found that women who took Depakote during pregnancy had four times the increased risk of congential malformations. The U.S. Food and Drug Administration (FDA) has warned pregnant women to speak with their doctor or healthcare professional before taking Depakote. While the risk varies for each defect, one thing is clear: women should be warned of these dangerous and potentially fatal side effects before becoming pregnant. Unfortunately, Abbott Laboratories is not currently required to warn users of these increased risks and, as a terrible result, babies continue to suffer.