The FDA ( Food and Drug Administration ) has notified healthcare professionals that children born to mothers who take the anti-seizure medication Valproate sodium or related products ( Valproic 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 epidemiologic studies that show that children born to mothers who took Valproate sodium or related products throughout their pregnancy tend to score lower on cognitive tests ( IQ and other tests ) than children born to mothers who took other anti-seizure medications during pregnancy.
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 off-label ( for unapproved uses ) for other conditions, particularly for other psychiatric conditions.
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.
In addition, healthcare professionals should weigh the benefits and risks of Valproate when prescribing this drug to women of childbearing age, particularly when treating a condition not usually associated with permanent injury or death.
Alternative medications that have a lower risk of adverse birth outcomes should be considered. Patients should not stop taking Valproate without talking to a healthcare professional.
The recommendation is related to: Valproate sodium ( Depacon ), Divalproex sodium ( Depakote, Depakote CP, and Depakote ER ), Valproic acid ( Depakene and Stavzor ), and their generics.
Source: FDA, 2011