Topamax Use In Pregnancy & Lactation

Pregnancy: Studies in animals have shown reproductive toxicity (Pharmacology: Toxicology: Non-Clinical Information: Reproductive and Developmental Toxicology under Actions). In rats, topiramate crosses the placental barrier. In humans, topiramate crosses the placenta and similar concentrations have been reported in the umbilical cord and maternal blood.
There are no adequate and well-controlled studies using TOPAMAX in pregnant women.
TOPAMAX can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk of congenital malformations (e.g., craniofacial defects, such as cleft lip/palate, hypospadias, and anomalies involving various body systems). This has been reported with topiramate monotherapy and topiramate as part of a polytherapy regimen.
In addition, data from other studies indicate that, compared with monotherapy, there is an increased risk of teratogenic effects associated with the use of AEDs in combination therapy. The risk has been observed in all doses and effects were reported to be dose-dependent. In women treated with topiramate who have had a child with a congenital malformation, there appears to be an increased risk of malformations in subsequent pregnancies when exposed to topiramate. There is an increased risk of pre-term labor and premature delivery associated with the use of AEDs, including topiramate.
Compared with a reference group not taking AEDs, registry data for TOPAMAX monotherapy showed a higher prevalence of low birth weight (<2500 grams). One pregnancy registry reported an increased frequency of infants who were small for gestational age (SGA; defined as birth weight below the 10^th percentile corrected for their gestational age, stratified by sex) among those exposed to topiramate monotherapy in utero. SGA has been observed in all doses and is dose-dependent. The prevalence of SGA is greater in women who received higher doses of topiramate during pregnancy. In addition, the prevalence of SGA for women who continued topiramate use later in pregnancy is higher compared to women who stopped its use before the third trimester. The long-term consequences of the SGA findings could not be determined. A causal relationship for low birth weight and SGA has not been established.
TOPAMAX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In treating and counseling women of childbearing potential, the prescribing physician should weigh the benefits of therapy against the risks and consider alternative therapeutic options. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Women of childbearing potential: TOPAMAX may cause fetal harm when administered to a pregnant woman. There is an increased risk of pre-term labor and premature delivery associated with the use of AEDs, including topiramate.
TOPAMAX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (see Use in Pregnancy & Lactation).
Breast-feeding: Topiramate is excreted in the milk of lactating rats. The excretion of topiramate in human milk has not been evaluated in controlled studies. Limited observations in patients suggest an extensive excretion of topiramate into breast milk. Diarrhea and somnolence have been reported in breastfed infants whose mothers receive topiramate treatment. Therefore, a decision should be made whether to discontinue breast-feeding or to discontinue the drug, taking into account the benefit of breast-feeding for the child and the benefit of the drug to the mother.