Topamax and Pregnancy
The FDA has classified Topamax as a pregnancy Category D medication due to the increased risk of cleft lip and/or cleft palate development in the fetus of a pregnant woman taking Topamax. In animal studies, the medication caused birth defects, miscarriages, and low fetal weight when it was given to pregnant animals. If you are taking Topamax and pregnancy occurs, talk to your healthcare provider so he or she can weigh both the benefits and risks before making a recommendation for your situation.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category D is given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
Data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry indicate that when Topamax is taken in early pregnancy (the first trimester), there is an increased risk of cleft lip and/or cleft palate (oral clefts) in the fetus. Oral clefts develop in the first trimester before many women know that they are pregnant, and because of this, all women of childbearing age should be made aware of this potential risk to the fetus from exposure to Topamax.
It is recommended that all women of childbearing age who are not planning a pregnancy should use effective birth control while taking Topamax. Keep in mind that Topamax may decrease the effectiveness of almost all birth control pills.
Topamax was also shown to cause potential problems according to animal studies. When given to pregnant rabbits, rats, or mice, Topamax caused birth defects, miscarriages, and decreased fetal weight. In small studies of Topamax in pregnant women, a few birth defects were seen, especially hypospadias (a birth defect in boys in which the opening to the urinary tract is not located at the tip of the penis). It is important to understand that in these studies, Topamax was taken with other seizure medications (which may have caused the birth defects).
However, it is important to note that seizures in a pregnant woman can also be damaging to the unborn child. Therefore, a pregnancy Category D medicine may be given to pregnant women if the healthcare provider believes that the benefits to the pregnant woman clearly outweigh any possible risks to the unborn child.
It is recommended that women taking Topamax receive folic acid supplementation, starting before conception (as is recommended for all epilepsy medications). If possible, Topamax should be avoided during the first trimester of pregnancy (unless it is necessary to control seizures).