Depakote Birth Side Effects Need Further Review: FDA Officials

FDA researchers are requesting that the agency take a closer look at Depakote side effects for pregnant women, to examine whether there is a link between the anti-seizure medication and developmental delays in children born to mothers who took the drug.

The recommendations come before an FDA advisory panel meeting scheduled for today to review the impact of a number of drugs on children.

For Depakote (divalproex), staff drug reviewers at the FDA identified six cases of children born with delayed development after their mothers took the drug during pregnancy, including several children who developed autism. They indicated that further research is needed to examine whether there is a direct causal relationship and the degree of risk of fetal exposure to the medication.

Depakote was created by Abbott Laboratories and is currently available as generic divalproex from several manufacturers. It was first introduced in 1983 and is approved to treat epilepsy, mania associated with bipolar disorder and migraines.

A “black box” warning has been on the medication’s label since 2006, warning about potential Depakote birth defects associated with use of the drug during pregnancy. A study done that year found that about 20% of babies born to mothers taking Depakote suffered serious problems, as opposed to other drugs which only had rates of between 1% and 10.7.

FDA researchers now indicate that the agency should also investigate the drug for ties to developmental problems such as autism. Although the limitations in the reported problems make it impossible to definitively conclude that there is a connection between Depakote and developmental delay, the staffers called for the FDA to commit more resources to exploring whether such a link exists.

Earlier this year, the American Academy of Neurology and American Epilepsy Society issued guidelines that urged pregnant women to avoid taking epilepsy drugs that include valproates, due to an increased risk of birth defects such as cleft palate and spinal bifida. Depakote becomes valproate once it has entered the body. The guidelines also recommended that women avoid taking more than one epilepsy medication at a time.