Study Suggests Increased Risk of Topamax Side Effects

Denver, CORecently published research attempts to shed light on the risk of Topamax birth defects and birth defects linked to other antiepileptic medications. The new research suggests that topiramate side effects could include an increased risk of complications during pregnancy and an increased risk of Topamax side effects in children.

A study conducted in Norway and published online by BJOG: An International Journal of Obstetrics & Gynaecology (05/11/11), examined the link between complications during pregnancy and delivery in women with epilepsy. Specifically, researchers examined risk factors such as severity of the epilepsy and dosage of the antiepileptic medications. Data from the group of women with epilepsy was compared with a control group of women who did not have epilepsy.

Researchers found that women who had epilepsy and used antiepileptic medications had an increased risk of severe pre-eclampsia, bleeding in early pregnancy, induction and caesarean section. Furthermore, women who used antiepileptic drugs also had an increased risk of malformations in their newborn.

The results led researchers to conclude, "Women with epilepsy using antiepileptic drugs had an increased risk of pregnancy and delivery complications, whereas women not using antiepileptic drugs had few complications." Researchers did note, however, that seizures, high doses of the medications and lack of folate did not explain the increased risks.

The BJOG study is the second to be published recently regarding the risks of anticonvulsant medications during pregnancy. The Journal of the American Medical Association (JAMA) recently published a study examining the link between first-trimester use of antiepileptic drugs and the risk of birth defects. Researchers found that of 1,532 infants exposed to a newer-generation anti-epileptic medication during the first trimester, 3.2 percent were diagnosed with a major birth defect, compared with 2.4 percent of those not exposed to an anti-epileptic medication.

Of infants exposed to topiramate, the generic version of Topamax, 4.6 percent were diagnosed with a major birth defect.

The US Food and Drug Administration (FDA) has changed the pregnancy category for Topamax from category C to category D, indicating that there is data suggesting a risk of birth defects in infants exposed to Topamax. Research from the North American Antiepileptic Drug Pregnancy Registry indicates infants who are exposed to topiramate in the first trimester are at an increased risk of oral clefts, which can require surgical intervention.