A new study has found more evidence that Depakote may be dangerous to a developing fetus. The study, conducted by Danish researchers, concluded that children who are exposed to valproate, the active ingredient in Depakote, face nearly three times the risk of developing Autism Spectrum Disorder (ASD) compared to children whose mothers do not use the epilepsy medication during the early months of pregnancy.
According to a HealthDay report, the study involved birth data that included nearly 656,000 children born in Denmark between 1996 and 2006 to 428,000 women. The researchers identified women who filled a Depakote prescription shortly before pregnancy through the day of the child’s birth. They also identified children with ASD, which can include both severe and milder forms of autism, and children with early-onset, more severe autism.
The study found that fetal exposure to valproate was associated with a 2.6 times more likely to suffer from ASD, after accounting for other autism risk factors. The risk was the same whether mothers took valproate alone or with another epilepsy drug, according to HealthDay.
In total, the research team identified 508 children who were likely exposed to valproate before birth, of which 14 developed autism. Of the group not exposed to valproate, only .08 percent developed ASD.
Depakote, which is approved for the prevention of migraines, treating acute manic episodes in bipolar patients and halting seizures in adults and children, has been associated with birth defects when taken by pregnant women. In 2009, the U.S. Food & Drug Administration (FDA) warned that it and similar drugs were associated with an increase risk of neural tube defects. The FDA has placed Depakote and all other valproate products in Pregnancy Category D, which means there is positive evidence of human fetal risk, but potential benefits may still warrant use of the drug in pregnant women.
“We know from previous studies valproic acid is associated with an increased risk of congenital malformations, and in recent years some animal and human studies have suggested maybe there are neuropsychological effects, like autism,” said author Dr. Jakob Christensen, lead author of the Danish study and a consultant neurologist at Aarhus University Hospital in Aarhus, Denmark. “Our study adds more evidence of that.”
The Danish study is slated to be presented Monday at the American Epilepsy Society meeting in Baltimore. HealthDay noted that the data and conclusions from the study should be viewed as preliminary until published in a peer-reviewed journal.