Depakote in Pregnancy May Cause Cognitive Impairment

The U.S. Food and Drug Administration (FDA) has warned the public that children born to women who take the anti-seizure medication <"">Depakote (valproate sodium) or related products (valproic acid and divalproex sodium), when pregnant, may give birth to babies with an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy.

The information is based epidemiologic studies that revealed that children born to mothers who took Depakote or related products throughout their pregnancy tended to score lower on cognitive tests, such as IQ tests, versus children born to mothers who took other anti-seizure medications while pregnant. The primary study conducted cognitive tests on children at three years of age; supportive studies conducted tests on children ages five to 16. Cognitive tests assess development in areas such as intelligence, abstract reasoning, and problem solving, said the FDA.

In 2009, the FDA warned that women of childbearing potential should only use drugs like Depakote when essential to manage their medical condition as birth defect risks are particularly high during the first trimester, before many women know they are pregnant. Women planning a pregnancy or who become pregnant while taking Depakote or a related medication should contact their healthcare professionals immediately.

Abbott Laboratories began marketing Depakote in the 1970s in the U.S., but its key element—valproic acid—has allegedly been linked to serious defects when taken by expectant mothers in their first trimester of pregnancy.

In addition to Depakote, valproic acid is marketed under the brand names Depakote ER, Depakene, Depacon, Depakine, and Stavzor. And, in addition to epilepsy, Depakote and similar drugs are used to treat mania (episodes of frenzied, abnormally excited mood) in people with bipolar disorder (manic-depressive disorder: A disease that causes episodes of depression, episodes of mania, and other abnormal moods). They are also used to prevent migraine headaches.

Last June, the New England Journal of Medicine (NEJM) published a study that found that Depakote and similar drugs increased the risk of six different birth defects: Spina bifida, atrial septal defect (a hole in the heart), cleft palate, hypospadias (an abnormality in the opening of the urethra in boys), polydactyly (extra fingers or toes), and craniosynostosis (one or more sutures on a baby’s skull close prematurely). These birth defects were more common in babies born to mothers who had taken valproic acid in their first trimester of pregnancy.

The NEJM study followed the FDA’s warning about the connection between birth defects and drugs like Depakote. At the time, the agency said the risk of neural tube defects occurring was much higher in babies born to mothers treated with one of these medications during the first 12 weeks of pregnancy, with the risk increasing to 1 in 20 babies, the agency said.

Also, said the FDA, women becoming pregnant while taking epilepsy drugs like Depakote should consider enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry, which can be reached, toll-free, at 1-888-233-2334. The registry gathers information about the safety of antiepileptic drugs during pregnancy.

This entry was posted in Depakote, Pharmaceuticals. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.