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Common Epilepsy Drug Ups Birth Defect Risk

Jun 10, 2010 | Parker Waichman LLP

Valproic acid and related epilepsy drugs sold under the names Depakote, Depakene, Depacon, and Stavzor, increased the risk of six different birth defects, according to a study published in the current edition of The New England Journal of Medicine (NEJM). The authors of the study said the findings present further evidence that these drugs should not be used to treat pregnant women when at all possible.

Valproate sodium is marketed as Depacon. Dilvalproex sodium is marketed as Depakote, Depakote CP, Depakote ER. Valproic acid is marketed as Depakene and as Stavzor. The U.S. Food & Drug Administration (FDA) first approved Depakene in 1978 for the treatment of epilepsy. More recently, the FDA approved valproate for the treatment of bipolar disorder and migraine headaches.

For the NEJM study, researchers led by Janneke Jentink, MSc, of the University of Groningen in Groningen, Netherlands, viewed data from eight studies that highlighted 14 birth defects that were more common among offspring of women who took valproic acid during the first trimester. Next, they identified infants with these 14 birth defects from the European Surveillance of Congenital Anomalies (EUROCAT) antiepileptic-study database, and compared them to a group of infants with birth defects not previously connected to use of this drug and to a group of infants with chromosomal abnormalities.

Six 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) – were more common in babies born to mothers who had taken valproic acid in their first trimester of pregnancy.

When compared with other epilepsy drugs, valproic acid increased the risk for all of these birth defects except craniosynostosis, the study showed. It also showed an increased risk of ventricular septal defect (a hole in the heart) when compared to other epilepsy drugs.

“Our findings provide further support for the recommendation of the American Academy of Neurology to avoid the use of valproic acid, if possible, in pregnant women,” the study authors wrote. “Since switching drugs during or just before pregnancy is difficult, the risks associated with valproic acid use should be routinely considered in choosing therapy for women with childbearing potential.”

Just this past December, the U.S. FDA warned that valproate and related medications had been associated with a higher risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, when taken by pregnant women. In a reminder to health care providers, the agency said women of childbearing potential should only use valproate if it is essential to manage their medical condition.

At the time, the agency said it would be working with the manufacturers of valproate products to address labeling changes.


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