Birth Defects Linked to Valproic Acid
6 Birth Defects More Common in Pregnant Women Who Take Epilepsy Drug
June 9, 2010 -- Women with epilepsy who take valproic acid during the first trimester of pregnancy are more likely to have children with birth defects than women who took other epilepsy drugs or no medicine to control their seizures during pregnancy.
The findings appear in the June 10 issue of the New England Journal of Medicine.
Valproic acid is also used to treat other illnesses, including bipolar disorder and migraines. Brand names include Depakote, Depakene, Depacon, and Stavzor.
Almost 3 million people in the U.S. have some form of epilepsy, according to the Epilepsy Foundation.
“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,” conclude the researchers, who were led by Janneke Jentink, MSc, of the University of Groningen in Groningen, Netherlands. “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.”
The researchers reviewed data from eight studies that highlighted 14 birth defects that were more common among offspring of women who took this epilepsy drug 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.
6 Birth Defects Linked to Valproic Acid
The researchers found that six birth defects were more common among children of women who took valproic acid during first trimester than children of women who did not take antiseizure drugs:
- 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)
- Craniosynostosis (one or more sutures on a baby’s skull close prematurely)
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.
“These findings support a relationship of these malformations with valproic acid specifically rather than to antiepileptic drugs generally or to underlying epilepsy,” the researchers write. The use of this drug is not considered a marker for more severe epilepsy, but information on the type or severity of epilepsy was not available. The new study also did not include information on the doses of valproic acid that women used during pregnancy.
“It’s a phenomenal drug for seizures and bipolar illness, but I won’t use it during pregnancy if I can help it,” says Catherine Birndorf, MD, a reproductive psychiatrist in New York City and the founding director of the Payne Whitney Women's Program at The New York Presbyterian Hospital-Weill Cornell Medical Center in New York. Birndorf typically counsels women who take this drug to treat bipolar disorder, not epilepsy.