Anti-Seizure Drug Depakote Needs More Study, FDA Staffers Say

Depakote, the Abbott Laboratories anti-seizure drug approved for treatment of epilepsy and bipolar mania, should be studied further to determine the risks of delayed development and birth defects in children whose mothers took the medication during pregnancy, Food and Drug Administration staff members said.

Depakote, which is generically known as divalproex, was approved in the United States in 1983. Since then, there have been six cases of developmental delays and other injuries to children who were exposed to the drug before birth that have raised concerns at the FDA.

“Further study is needed to further elucidate causality and degree of risk of fetal exposure to (Depakote) and subsequent developmental delay in children,” said an FDA staff memo dated May 6 and released today.

Earlier Depakote Warnings

Depakote’s packaging already carries a prominent “black box” warning about the risks of birth defects and the drug has recently been associated with children who have lower IQs.

The FDA also has warned about the risk of suicidal thoughts and behaviors in people taking nearly two dozen anti-seizure drugs, including Depakote. The agency ordered makers of the drug to strengthen side-effect warnings on the products’ labeling.

An Abbott spokeswoman said the drug company will “continue to participate in discussions with the FDA and its advisers to further evaluate any risks related to anti-epileptic drugs, neurodevelopment and pregnancy,” according to a Reuters news report.

Abbott said Depakote is the only effective anti-seizure that works for many women and that doctors and patients should carefully consider both the risks and benefits of the drug before taking it.

FDA Advisory Panel to Meet

An advisory panel of medical experts is scheduled to meet next week and review the safety of several drugs for children. Depakote and the risks of birth defects and developmental delays associated with the drug figures to be part of that discussion.

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