Study Identifies Additional Epilepsy Drug Pregnancy Risks

The use several popular anti-epileptic drugs (AEDs) during pregnancy, such as Depakote, Tegretol, Lamictal and others, may increase the risk of more birth defects than previously believed, according to a new report.  

In a study presented this week at the World Congress of Neurology, researchers from Denmark indicated that pregnancy side effects of epilepsy drugs may increase the risk of a child being born prematurely, with low birth weight or with an abnormally small head.

These potential side effects are in addition to the previously established epilepsy drug pregnancy risks, which include an increased chance of the baby suffering congenital birth defects.

Researchers looked at data on about 1 million pregnancies in Denmark between 1997 and 2008, finding that low birth weight, preterm births and small head circumference were much more common among women who took epilepsy drugs during pregnancy than among those that did not.

The findings have not yet been peer reviewed or published, and researchers are still in the process of analyzing data on fetal deaths linked to the use of epilepsy drugs.

Depakote Birth Defects

The report comes following a number of similar studies that have looked at the potential pregnancy risks of Depakote, which has been linked to developmental delays and a risk of birth defects, such as spina bifida, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems; especially when the drug is taken during the first 28 days, when neural tube closure and other critical formations are taking place.

In July, researchers from Norway published a study in the medical journal Epilepsia that found that children born to mothers who used AEDs were more likely to have children with developmental delays. They found that the rates of autism, gross motor control problems, speech and birth defects were increased for children taking the drugs at 18 months and at 36 months.

In April, a report published by Danish researchers in the Journal of the American Medical Association (JAMA) found that mothers who took Depakote during pregnancy were three times more likely to have a child with an autism spectrum disorder than those who did not take the drug. British researchers released a report earlier this year with similar findings of developmental disorders tied to Depakote and similar drugs.

Depakote was approved in the United States in 1978 for treatment of certain forms of epilepsy. However, the FDA added a “black box” warning to the medication in 2006, indicating that unborn children may face a risk of birth defects from Depakote. That warning came after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect.

A number of families are now pursuing a Depakote birth defect lawsuits on behalf of children whose mother was given the epilepsy drug during pregnancy, alleging that the drug maker failed to adequately warn consumers or the medical community about the potential risks.