Epilepsy Drug Side Effects Linked to Developmental Delays

Side effects of several drugs that may be used during pregnancy to treat epilepsy, such as Depakote and Lamictal, may increase the risk of children suffering developmental delays and other serious birth defects, according to the findings of new research.  

In a study released on-line this week by the medical journal Epilepsia, researchers from Norway found that children born to mothers who used certain epilepsy drugs during pregnancy had a higher risk of abnormal gross motor control, autism, speech and congenital malformations when compared to children who were not exposed to the medications during pregnancy.

The research looked at tens of thousands of Norwegian children and found 333 that had been exposed to some form of antiepileptic drug while in the womb. They compared those children to children born to mothers who had epilepsy, but who had not taken antiseizure drugs. 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.

The drugs the women took included Depakote, Lamictal, Tegretol, and combinations of drugs. All were linked to adverse outcomes.

Depakote Birth Defect Studies

The report comes following a number of similar studies that have looked at the potential pregnancy side effects 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 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.