Fetal Exposure to Common Epilepsy Drugs May Harm Kids' IQ: FDA
THURSDAY June 30, 2011 -- The U.S. Food and Drug Administration on Thursday advised doctors to warn women of childbearing age that fetal exposure to certain drugs used to control seizures or migraines appears to diminish intellectual abilities in offspring.
The drugs include so-called "valproate products" -- medications such as valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, Depakote ER), valproic acid (Depakene, Stavzor), and their equivalent generic formulations, the FDA said in a statement.
Children born to women who take these medications during their pregnancy "have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy," the FDA said.
The agency said it based its conclusions on epidemiological studies that showed that fetal exposures to the drugs tended to correlate with lower scores on IQ and other cognitive tests.
Valproate drugs are FDA-approved for use against epilepsy, migraine and bipolar disorder, although the agency notes that they are also used "off-label" for other conditions, mainly other psychiatric disorders.
The drugs have also long been linked to an increased risk of birth defects known as neural tube defects, the agency noted.
The FDA advises that doctors counsel women of childbearing age of the risks to offspring associated with valproate products, and "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."
In late 2010, a Swedish study of over 1,200 teenage children born to women with epilepsy found that those born to women who took two or more epilepsy drugs while pregnant fared worse in school than peers with no prenatal exposure to those medications.
The findings, published in Epilepsia, echoed earlier research that linked prenatal exposure to epilepsy drugs, particularly valproic acid medications (such as Depakene and Depakote), to negative effects on a child's ability to process information, solve problems and make decisions.
"Our results suggest that exposure to several anti-epileptic drugs in utero may have a negative effect on a child's neurodevelopment," study author Dr. Lisa Forsberg of Karolinska University Hospital told HealthDay at the time.
Forsberg recommended that women with epilepsy plan their pregnancies. "That way, they and their doctors can come up with individual treatment plans that make the pregnancy safe for both mother and child," she said.
Posted: June 2011