Women who have taken Depakote or similar drugs during pregnancy have reported birth defects including developmental delays, heart defects, and other deformities in their newborns. Data from the North American Antiepileptic Drug Pregnancy Registry (NAAED) suggests that the rate of deformities in babies exposed to Depakote in the womb is nearly four times higher than those exposed to different antiepileptic drugs. In light of these reports, women who took the drug while pregnant are now taking legal action against the manufacturer.
If you took Depakote during pregnancy and delivered a child with birth defects, you may be able to file a lawsuit to recover compensation. Please fill out our free case evaluation form to learn more about your legal rights.
In 2009, the U.S. Food and Drug Administration published a memo warning consumers that Depakote, when taken during the first trimester of pregnancy, could cause major birth defects in babies, including:
In December 2009, an official drug safety report was published for valproate. It reported that about 1 in 1,500 babies is born with a neural tube defect in the United States; however, that number jumps to 1 in 20 babies when the mother has been treated with valproate during the first trimester of her pregnancy. In a study performed by the NAAED, it was reported that nearly 11 percent of babies born to women taking valproate sodium-based drugs reported a major malformation, with only a 3 percent deformity rate in offspring from mothers using different drugs. The memo warned women who are able to conceive that they should consider alternative therapies to Depakote and use birth control. Depakote and other valproate sodium-based medications now contain black box warnings, which were initiated following the safety report, about the drugs’ potential for causing birth defects in newborns when taken during pregnancy.
In 2011, the FDA published a safety announcement on Depakote, reporting that studies found a link between children scoring lower on cognitive tests and exposure to the drug while in the womb. The cohort study performed in the United States and United Kingdom found that after being exposed to Depakote, three-year-old children received lower Differential Ability Scale (DAS) scores than those exposed to other epilepsy treatments. The FDA reported that these lower scores could signal impaired cognitive development in children.
In August 2011, two lawsuits were filed against Abbott Laboratories Inc. alleging that Depakote caused birth defects in children who had pre-natal exposure to the drug. According to the complaint, Depakote caused birth defects in four dozen minors whose mothers took the drug during their first trimester of pregnancy, and the plaintiffs allege that the company failed to provide an adequate warning for potential side effects.
The plaintiffs claim that Abbott has been aware of the higher birth defect rates associated with Depakote since the drug’s introduction to the market in 1978. It was reported that the incident rate of neural tube defects was ten times greater when a fetus was exposed to Depakote than when exposed to other antiepileptic drugs, according to studies done as early as 1995. Despite new pharmaceutical research finding alternative drugs with lower birth defect rates, Abbott failed to communicate the “true nature and extent of the risk in its product labeling and warnings to physicians and consumers,” according to the complaint. Plaintiffs accuse the company of failing to adequately test or provide warnings for the drug before releasing it into the market.
The attorneys working with our website are currently investigating potential lawsuits on behalf of mothers who used Depakote during the first trimester of their pregnancy. If your child has suffered from a birth defect or deformity due to Depakote use, you may be entitled to compensation. Fill out our no cost, no obligation case review form to find out if you are eligible to participate in litigation.