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If a woman takes zonisamide during pregnancy, will it hurt the baby?

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New comprehensive downloadable medication sheet
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In the United States, the Food and Drug Administration (FDA) assigns each medication to a Pregnancy Category according to whether it has been proven to be harmful in pregnancy. Zonisamide is listed in Pregnancy Category C. This indicates that caution is advised, but the benefits of the medicine may outweigh the potential risks. Studies in animals have shown some harm to the baby, but there haven't been any good studies of results in women.

Talk to your doctor or another health professional if you are pregnant or plan to become pregnant. We don't yet have enough information to be able to estimate the risk of various types of birth defects that might occur if zonisamide is taken during pregnancy. We also don't know enough to compare the risk with zonisamide to the risk with other seizure medicines. The risk of birth defects is generally higher for women who take more than one seizure medication and for women with a family history of birth defects.

Women who are capable of becoming pregnant should take at least 400 mcg (0.4 mg) of folic acid (folate) daily to help prevent a type of birth defect called a neural tube defect. (The best-known of these is spina bifida, in which the spinal cord is not completely enclosed.) Women at high risk, such as those with a history of this kind of defect in a previous pregnancy, should take 4000 mcg (4 mg) daily, beginning before they become pregnant.

How much zonisamide is passed through breast milk is not known for certain, but the way the body uses it suggests that probably a large portion does enter the milk. If you want to breast-feed your baby, check with your doctor.


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