June 30, 2011
SAFETY ALERT: Valproate May Impair Cognitive Development in PregnancyThe FDA has notified healthcare professionals that children born to mothers who took valproate sodium, valproic acid, or divalproex sodium during pregnancy have an increased risk of lower cognitive test scores than children exposed to other antiepileptic medications during pregnancy. This conclusion is based on the results of epidemiologic studies of cognitive tests performed in children 3–16 years of age. The long-term effects on cognitive development from exposure to valproate sodium or related products during pregnancy are unknown. It is also not known whether these effects occur when fetal exposure is limited to less than the full duration of pregnancy, such as the first trimester.
The FDA has evaluated all available evidence to date, and will be adding information about the risk of lower cognitive test scores to the valproate product labeling. Healthcare professionals should inform women of childbearing age of the increased risk for adverse effects on cognitive development with prenatal valproate exposure, and should continue to counsel women of childbearing potential taking valproate about the increased risk of major malformations, including neural tube defects, when valproate is used during pregnancy.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm261610.htm.