Researchers from Denmark warn that the side effects of Depakote use during pregnancy may result in lower school performance for children later in life.
A study published last month in the medical journal JAMA Neurology, is the latest in a growing body of research to suggest that the anti-seizure medication can negatively impact the development of children exposed to it in the womb. According to the findings, children whose mothers took the drug performed less aptly than their peers on both math and language tests.
Depakote (valproate) is prescribed for treatment of seizures and bipolar disorder, as well as migrain headaches, but has been linked to a number of serious health concerns for unborn children in recent years.
In 2006, the FDA added a “black box” warning about the potential Depakote pregnancy side effects, after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect.
In May 2013, the FDA put new restrictions on Depakote pregnancy use, contraindicating it for pregnant women, but only when it was used for the treatment of migraines. The agency did not contraindicate it for pregnant women using it to treat epilepsy. The FDA changed all valproate-based drugs from a class “D” to a class “X” pregnancy drug, but only as they pertain to migraines.
This latest study looked at data on nearly half a million children born in Denmark from 1997 to 2006, who participated in national tests. They looked for children exposed to a number of antiepileptic drugs (AEDs) in utero, including Depakote, phenobarbital, Trileptal, Oxtellar XR, Lamictal, Klonopin, and Tegretol. Lamictal was used as a baseline.
According to the findings, children who were exposed to Depakote before they were born scored worse on both language and math tests in the sixth grade, when compared to their peers. Those exposed to Klonopin suffered lower language test scores, but not lower math scores, the study found. Other drug exposures appeared to have no effect on academic performance.
“Maternal use of valproate was associated with a significant decrease in school performance in offspring compared with children unexposed to AEDs and children exposed to lamotrigine,” the researchers concluded. “Findings of this study further caution against the use of valproate among women of childbearing potential.”
Abbott Laboratories and AbbVie, a subsidiary it spun off, have faced hundreds of Depakote lawsuits in state and federal courts nationwide. Plaintiffs say the company should be held liable for failing to warn women and the medical community about the risks associated with using the medication during pregnancy.
Before the drug’s patent expired in 2007, Depakote was a blockbuster drug generating about $1.5 billion in annual sales for AbbVie’s predecessor.