Valproate Products: Risk of Impaired Cognitive Development in Children Exposed In Utero

August 1 2011
Valproate Products: Risk of Impaired Cognitive Development in Children Exposed In Utero
August 1 2011

■ Including valproate sodium (Depacon), divalproex sodium (De-pakote, Depakote CP, and Depakote ER), valproie acid (Depakene and Slav/or), and their generics The FDA notified healthcare professionals that children born to mothers who take the anti-seizurc medication valproate sodium or related products (valproie acid and divalproex sodium) during pregnancy have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy. This conclusion is based on the results of epidcmiologic studies that show that children born to mothers who look valpro­ate sodium or related products throughout their pregnancy lend to score lower on cognitive tests (IQ and other tests) than children born to mothers who took other anti-seizurc medications during pregnancy. See the Drug Safety Communication for a data sum­mary and additional information. Valproate products are FDA-approved drugs to treat seizures, and manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), and to prevent migraine headaches. They are also used oil-label (for unapproved uses) for other condi­tions, particularly for other psychiatric conditions. Healthcare professionals should inform women of ehildbearing age of the increased risk for adverse effects on cognitive develop­ment with prenatal valproate exposure, and should continue to counsel women of ehildbearing potential taking valproate about the increased risk of major malformations, including neural tube defects, when valproate is used during pregnancy. Source: FDA