Emerging data from a pregnancy registry suggest an association between LAMICTAL ® (lamotrigine) and an increased risk of non-syndromic oral clefts

The U.S. Food and Drug Administration (FDA) lists Lamictal in Pregnancy Category C. This indicates that caution is advised, but the benefits of the medication may outweigh the potential risks. So far there is no indication that Lamictal causes serious birth defects, but there have been no well-controlled studies in women, and studies in animals have shown some harm to the fetus.

The risk of birth defects is 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 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. Whether folic acid is effective in preventing defects has not been proven, however, so the doctor may recommend a check-up using ultrasound during the 18th to 20th week of 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. This appears to be particularly true for Lamictal. Therefore, the doctor may recommend checking the level of Lamictal in the blood regularly during pregnancy so that the dosage can be adjusted as needed.

The risks, benefits, and options should be discussed with women taking Lamictal who are interested in breast-feeding. The baby will get some Lamictal through the milk, and its possible effects are unknown. For this reason, breast-feeding while taking Lamictal is not recommended.