Depakote Pregnancy Use May Cause Cognitive Impairment, FDA Warns

Federal drug regulators are warning that side effects of Depakote and other valproate-based epilepsy drugs may increase the risk that pregnant women will give birth to a child with impaired cognitive development. 

The FDA issued the Depakote pregnancy warning on June 30, 2011, after the agency analyzed the findings of studies that show children born to mothers who took Depakote while pregnant scored lower on cognitive tests than children whose mothers took other anti-seizure drugs while pregnant.

New warnings will be added to the label for Depakote and other related drugs, such as Depacon, Depakene and Stavzor, as well as their generic equivalents.

Unless the use of a valproate-based drug is essential to avoid permanent injury or death, doctors should consider alternatives to Depakote for women of childbearing age, unless it is paired with effective birth control, the agency warned. Women already taking the drug should not stop using it until they talk with their healthcare professional.

The FDA warned that serious problems may occur when someone suddenly stops taking Depakote or other valproate-based drugs.

Depakote was approved in the United States in 1978 for treatment of certain forms of epilepsy. However, Depakote pregnancy use has been linked to an increased risk of a number of severe birth defects, especially when the drug is taken during the first 28 days, when neural tube closure and other critical formations are taking place.

In 2006, the FDA added a “black box” warning about the potential risk of Depakote birth defects after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect. Birth defects associated with Depakote include spina bifida, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems.

In May 2010, researchers found that Depakote problems for infants could occur after using the drug as early as the first trimester, which means that by the time many women discover they are pregnant, it could be too late to get off the drug and avoid birth defects for their unborn child.

In recent months, a growing number of Depakote lawsuits have been filed against Abbott Laboratories by families of children born with spina bifida and other birth defects or malformations.