Epilepsy Drug May Cause Birth Defects

While there are always risks in pregnancy, those risks can be compounded in epilepsy patients. Medications, as well as seizures, can be problematic for the unborn fetus. Recently a new study, though based on a small test population, has shown evidence that Topiramate, prescribed under the name of Topamax, a drug used to treat epilepsy, may lead to birth defects in babies. This compounds the risks to consider if an epilepsy patient is considering pregnancy.

Johnson & Johnson's epilepsy drug, Topamax, a common anti-seizure medication, is prescribed to one in five patients and has become one of the top treatments for migraines over the past few years. The new study was one of the first to link Topamax to an increased risk of birth defects seen in babies born to mothers with epilepsy, but is not the first epilepsy treatment drug to be linked to birth defects. Epilepsy is a disorder best recognized by its powerful seizures, and effects 2.7 million in the U.S.

During the recent study, released in the journal Neurology, researchers collected data from women who were using Topamax with no other epilepsy treatment and those that were taking the drug in combination with another epilepsy drug and became pregnant. The research team studied 203 women, who were a part of the U.K. Epilepsy and Pregnancy Register, set up to study the safety of epilepsy drugs on unborn children. The mother's studied were taking Topamax for epilepsy treatment. There were 18 babies lost to spontaneous abortions, five induced abortions and several stillbirths. Of the 178 babies born during the study, 16 had major birth defects such as cleft palates and genital defects. Only three of the mothers were taking only Topamax and the other 13 mothers were taking Topamax along with another epilepsy drug. The rate of cleft palates or cleft lips and the rate of male babies with genital defects were 11 times higher in the babies studied. In the general population, male genital defects are only seen in around 1 of 300 children, researchers say.

More than 4 million people worldwide have used Topamax and the risks associated with the drug are comparable to other epilepsy treatment drugs. However, researchers feel larger studies need to be conducted in order to form definite conclusions. While Topamax isn't the only epilepsy drug that has been linked to birth defects, researchers didn't expect to see the higher percentage of birth defects found in children born from mothers who were taking Topamax in combination with other epilepsy drugs. Valproate, another drug used to treat epilepsy, has also been linked to birth defects or fetal death in around 20 percent of women being treated with the drug. Doctors already warn pregnant women of the possible consequences of taking Valproate while pregnant.

The FDA classified Topamax as a category C classification for pregnancy, based on prescribing information, as a result of the drug causing birth defects, miscarriages and a decrease in fetus weight during animal studies, even though the drug had not been studied in pregnant women.

Jacqueline A. French, M.D. says there are three major databases currently tracking babies born to mothers taking epilepsy drugs to determine the number of birth defects. Only the report on Topamax has been released. Once the other study results are released, researchers should know more in regards to the true effects and risks of the drugs.

Doctors say epilepsy patient's must continue to take their medication during pregnancy due to the risks seizures may cause to an unborn fetus or the patient, but the American Academy of Neurology recommend pregnant women with epilepsy, only take the lowest effective dosage and only one treatment drug, when possible. Patients using the medication for treatment of migraines, a situation that doesn't cause harm to the unborn baby, may want to use another form of treatment while pregnant or planning to become pregnant, to avoid the possible birth defects in their children. Topamax product information states that pregnant women should only use the drug where the benefits exceed the risks. Due to Epilepsy drug effects, close monitoring of pregnant women who are taking Topamax is encouraged.