Depakote (generic: dilvalproex sodium, a derivative of valproic acid), is a widely used prescription drug developed to treat epilepsy, migraines and bipolar disorder. It was approved by the FDA in 1978 to treat certain types of epilepsy. As early as the 1980s, it was discovered to have adverse effects during pregnancy, yet pregnant women were often not made aware of the risks. Studies have shown that when taken during pregnancy, Depakote leads to birth defects, which may include:
- Spina Bifida
- Hand Deformations
- Cleft Palate
- Skeletal Defects
- Abnormal Skull Development
FDA Acknowledges Depakote Risk
In 2006, the Federal Drug Administration (FDA) added a “black box” warning about the possible risk of Depakote birth defects after a study found that 20 percent of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect. The black box is the highest warning the FDA can require for a drug and is only authorized for the most severe cases.
In 2011, the FDA also linked valproic acid exposure in the womb to lowered cognitive function. The findings showed that children who had been exposed to Depakote scored lower on IQ tests than those whose mothers took another anti-seizure medication.
Recent Study Reveals Significant Spina Bifida Risk
Researcher De Jong-van den Berg from The University of Groningen in the Netherlands concluded that babies exposed to valproic acid during the first trimester were 12.7 times more likely to be born with spina bifida compared to babies whose mothers did not take the drug.
Likewise, the study found that babies whose mothers took Valproic Acid were also:
- More than twice as likely to develop an atrial septal defect (which involves the heart)
- Twice as likely to be born with an extra digit on the hand (polydactyly)
- Five times as likely to have a cleft palate (a defect of the upper lip and roof of the mouth)
- Nearly seven times more likely to have craniosynostosis (premature fusion of the skull during fetal development that limits skull and brain growth)
If you took Depakote during pregnancy and your child developed any kind of birth defect, you may be entitled to financial compensation. Contact our experienced attorneys today for a free consultation. We will listen to your story and help you determine the best course of action for your case.