Study: Topamax May Increase Birth Defect Risks
An increased risk of birth defects has been seen in babies whose mothers took epilepsy drugs during pregnancy. The study published in the latest issue of the journal Neurology linked Topamax (topiramate) to birth defects in humans confirming its findings based on studies done previously on animals. Topiramate, brand name Topamax, is a drug for epilepsy as well as used by some migraine patients.
"More research needs to be done to confirm these results, especially since it was a small study," said researcher John Craig, MRCP, of the Royal Group of Hospitals in Belfast, Northern Ireland. He felt that though the study focused only on epilepsy patients, migraine sufferers need to be studied as well as the drug was used for both ailments and also as migraine sufferers in the childbearing age were more.
The study focused on 203 women who became pregnant while taking topiramate either alone or with other epilepsy drugs. The results showed that of the 178 babies born, 16 or 4.8% suffered from major birth defects, four of the babies had cleft palettes or cleft lips while four male babies had genital defects, with two of them with major defects. Basically the birth defects were 11-14 times higher in women who used the drug than non users.
Kara Russell, a spokeswoman for Topamax manufacturer Ortho McNeill Neurologics said, "We continue to support studies to provide clarity on the use of our drug in this population, but it is really hard to reach a conclusion based on the small sample sizes in this study. We should know more soon when the other databases report on this drug.”
Discontinuing epilepsy treatment while pregnant can be dangerous for both the patient and the baby. During the time the mother has a seizure and for an immediate period later, the oxygen levels being delivered to the fetus and placenta is low and this could result in the baby’s heart rate dropping- a sign of fetal distress. Concerns of fetal and placental injury during the mother having a seizure can also lead to increased chances of miscarriage. NYU professor of neurology Jacqueline A. French, MD, says "it's a double whammy, the baby has already been exposed and with withdrawal there is the added risk that a woman will suffer a seizure."
The American Academy of Neurology recommends that women with epilepsy who are considering getting pregnant should take only one drug to control the seizures and these should be in the lowest possible dosage to minimize risks.