Epilepsy Drug Side Effect May Increase Pregnancy Risks: Study

Women who take epilepsy drugs like Topamax, Depakote and Tegretol, may be more likely to experience pregnancy complications than women with and without epilepsy who do not take anti-seizure drugs, according to the findings of a new study.  

For years, women with epilepsy have been told that epileptic seizures were dangerous to their unborn child and the welfare of their pregnancy, however Norwegian researchers say that their findings, which were published in the current issue of BJOG: An International Journal of Obstetrics & Gynaecology, may indicate that women who take epilepsy drugs have more problems during pregnancy than those that do not.

Much attention has been focused lately on birth defects from epilepsy drugs, and this study again found a much higher rate of malformations among women who took the medications during pregnancy. However, the researchers also found that women taking epilepsy drugs were also at increased risk of pre-eclampsia (pregnancy-induced hypertension and protein buildup), which can be fatal, as well as vaginal bleeding, postpartum hemorrhage, and increased risks of delivery complications that required vaginal operative deliveries or caesarean section deliveries.

The researchers, from the University of Bergen, determined that the increased risks appeared to be mainly associated to the use of epilepsy drugs and were not due to seizures, obesity, lack of folate or unusually high doses of antiepileptics.

The study looked at more than 400 women who delivered babies in Bergen, Norway between 1999 and 2006, half of whom had epilepsy and half who did not. Researchers found that 8 percent of women taking antiseizure drugs were diagnosed with pre-eclampsia during pregnancy, which can kill both mother and child. That compares to only 3% among women who do not take the drugs, whether they had epilepsy or not.

The researchers also found that women taking the drugs had double the risk of requiring induced labor and emergency Cesarean sections and were 6.5 times as likely to have a child with birth defects.

The study comes amid growing concerns about side effects of epilepsy drugs on unborn children, particularly involving use of Depakote, Tegretol and Topamax.

Depakote was approved in the United States in 1978 for treatment of certain forms of epilepsy. However, Depakote pregnancy side effects have been linked to an increased risk of severe birth defects when taken during the first trimester, especially during the first 28 days when neural tube closure and other critical formations are taking place.

In 2006, the FDA added a “black box” warning about the potential risk of Depakote birth defects after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect. Birth defects associated with Depakote include spina bifida, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems.

In recent months, a growing number of Depakote lawsuits have been filed against Abbott Laboratories by families of children born with spina bifida and other birth defects or malformations.

Similar pregnancy side effects have been identified with carbamazepine, which is marketed as Tegretol, Carbatrol, Epitol and Equetrol. According to a study last year, 3.3% of women who took the drug during the first trimester gave birth to children with malformations or defects. The Tegretol birth defect side effects were assoicated with a 2.6 times higher risk of having a child born with spina bifida than women who were not exposed to carbamazepine.

Topamax (topiramate), which is a newer epilepsy drug approved in 2004, has also been associated with a risk of problems when used during pregnancy.

On March 4, the FDA announced that new warnings about the risk of oral clefts from Topamax would be added to the medication’s label after data showed infants exposed to Topamax during the first trimester of pregnancy, when many women do not even know they are pregnant, face an increased risk of cleft lip or cleft palate.

A number of women who have given birth to children with a defect or malformation after using the drug while pregnant are considering a potential Topamax lawsuit against the drug makers as a result of their failure to research the pregnancy risks associated with the medication or adequately warn about the risk of Topamax cleft palate and lip problems.