The U.S. Food and Drug Administration (FDA) lists Sabril in Pregnancy Category C, known to cause birth defects in animals, and suspected to be able to produce birth defects in people. 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 Sabril is taken during pregnancy. We also don't know enough to compare the risk with Sabril to the risk with other seizure medicines. The risk of birth defects is generally higher for women who take more than one AED and for women with a family history of birth defects.

Women who are capable of becoming pregnant should take at least 400 micrograms (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. Pregnant patients taking SABRIL are encouraged to call the North American Antiepileptic Drug (NAAED) Pregnancy Registry at 1-888-233-2334, or visit online at www.aedpregnancyregistry.org.

Sabril is excreted in breast milk and could cause toxicity in the baby. If you want to breast-feed your baby, check with your doctor about what seizure medicine would be best for you. Women who are capable of becoming pregnant should take at least 400 micrograms (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.

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