• Defective Drug Side Effects

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New research suggests that antiseizure drug valproate is linked to a significantly higher rate of serious birth defects in babies compared with other similar drugs evaluated in the study.

According to the new study, published in the journal of Neurology , about 20 percent of epileptic women who take valproate during pregnancy will birth a baby with severe adverse outcomes including congenital malformations and fetal death.

Risks of Antiseizure Drugs

Because antiseizure drugs generally pose a risk of birth defects from maternal use, the American Academy of Neurology and other organizations set guidelines and regulations for treating women with epilepsy during pregnancy.

While the guidelines suggested only one antiepileptic drug be used at a low effective dose before conception, they never distinguished whether or not one drug may pose a higher risk of birth defects than another.

“There were no data comparing the adverse fetal effects of the different antiepileptic drugs,” said the lead author of the study Dr. Kimford J. Meador. “In the last two years, however, seven studies have come out, all showing an increased risk with valproate.”

Results of the New Study

Meador and his colleagues at the University of Florida were originally focused on the impact that antiseizure drugs have on neurodevelopment later in life. However, as they began to monitor these children “the early effects came to light.”

The study evaluated 333 epileptic pregnant women who were all receiving antiseizure therapy with a single drug: carbamazephine, lamotrigine, phenytoin, or valproate. Researchers found that the rate of serious adverse fetal birth defects was 20 percent for valproate, almost 11 percent for phenytoin, 8.2 percent for carbamazephine, and 1 percent for lamotrigine.

Valproate was by far the most dangerous antiseizure drug and was linked to two fetal deaths and 12 congenital heart malformations including structural heart abnormalities, skull deformities, cleft palate, kidney swelling, and others.

Experts recommend valproate not be used as an antiepileptic therapy in pregnant women.

Has Your Child Developed Drug-Related Birth Defects?

If you took valproate or other defective drug that you suspect caused your child to develop birth defects, please contact us today to speak with a qualified and experienced attorney who can protect your legal rights and interests.