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. Depakote is listed in Pregnancy Category D. This means that there is a risk to the baby, but the benefits may outweigh the risk for some women.
In fact, a large majority of women who use Depakote during pregnancy have normal, healthy babies. Certain types of defects are increased (especially if Depakote is taken during the first 3 months of pregnancy) but they are still relatively uncommon. The risk of defects is higher for women who take more than one seizure medicine. Women with a family history of birth defects also have a higher risk.
Women with epilepsy who are pregnant or thinking about becoming pregnant should talk to their doctor about their seizure medicines. Taking more than one seizure medicine may increase the risk of birth defects, so doctors sometimes gradually reduce the number or amount of seizure medicines taken by women planning for pregnancy. This is not done routinely, however, because it increases the risk of seizures. Some kinds of seizures can injure the baby, so do not stop using seizure medicines or reduce the amount without the doctor’s OK.
All women who are capable of becoming pregnant should take at least 400 mcg (0.4 mg) of the vitamin called folic acid every day because it helps to prevent one type of birth defect. (The most well-known of these is spina bifida, in which the spinal cord is not completely enclosed.) These defects are more common in the babies of women who take Depakote during the first 4 to 6 weeks of pregnancy. If the doctor thinks a woman is at especially high risk, a much larger dose of folic acid—4000 mcg (4 mg) per day—may be recommended. There's no proof that the folic acid will prevent the defects, however, so the doctor may recommend a check-up later in pregnancy.
About 20% to 35% of women have seizures more often during pregnancy because of changes in hormones or changes in how their seizure medicine is handled by the body. It is helpful for the doctor to check the levels of medicine in the blood regularly during pregnancy so that the dosage can be adjusted if necessary.
Breast-feeding by mothers taking Depakote should be safe for healthy, full-term newborns. The amount of medicine the baby gets through the milk is much less than the amount that doctors safely give to babies who take Depakote for seizures.
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