FDA Staff Urge Review Of Developmental Delay, Autism Linked To Depakote

In news just out this morning, FDA scientific staff urge the agency to undertake further review of the anti-seizure drug Depakote, commonly used for various seizure disorders as well as a so-called mood stabilizer in bipolar disorder, due to possible links to cases of developmental delay and autism in children of mothers taking the drug while pregnant. Depakote, made by Abbott Labs, is also known as divalproex in generic form.

"Six cases received since its approval in 1983, including two siblings reported to have autism, 'raise concerns,' Food and Drug Administration staff wrote in a May 6 memo released on Friday.

"Limitations in the reports 'make it impossible to definitively conclude' the drug played a role, and genetics or other factors may have contributed, especially in the two sibling cases of autism, the FDA reviewers said.

"'Further study is needed to further elucidate causality and degree of risk of fetal exposure to (Depakote) and subsequent developmental delay in children,' they added."

In April, a study found that Depakote use during pregnancy led to significantly lower IQ scores in offspring. Last year, a British study reported a sevenfold increase in the risk of developing autism in the offspring of mothers who took Depakote in utero.

Depakote has also been linked to ovarian cysts.