Can I take topiramate while pregnant or breastfeeding?

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334. Information about the North American Drug Pregnancy Registry can be found at http://www.aedpregnancyregistry.org/. Risk Summary Topiramate 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 major congenital malformations, including but not limited to cleft lip and/or cleft palate (oral clefts) and of being small for gestational age (SGA) [see Human Data] . SGA has been observed at all doses and appears to be dose-dependent. The prevalence of SGA is greater in infants of women who received higher doses of topiramate during pregnancy.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): topiramate (oral), REMEDYREPACK INC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Maternal doses of topiramate up to 200 mg daily produce low levels in infant serum. Sedation and diarrhea have been reported occasionally in breastfed infants, but most infants tolerate the drug in milk well. In a few infants, no long-term adverse effects on growth and development have been seen. Monitor the infant for diarrhea, drowsiness, irritability, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of anticonvulsant or psychotropic drugs.

“Summary of Use during Lactation”, LactMed record “Topiramate” (LM390), quoted verbatim. Everything LactMed reports about Topiramate while breastfeeding.

8.2 Lactation Risk Summary Topiramate is excreted in human milk [see Data]. The effects of topiramate on milk production are unknown. Diarrhea and somnolence have been reported in breastfed infants whose mothers receive topiramate treatment. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for topiramate and any potential adverse effects on the breastfed infant from topiramate or from the underlying maternal condition.

Prescribing label, section “8.2 Lactation” (opening excerpt): topiramate (oral), REMEDYREPACK INC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.