Can I take levetiracetam while pregnant or breastfeeding?

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including levetiracetam extended-release tablets, during pregnancy. Encourage women who are taking levetiracetam extended-release tablets during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary Prolonged experience with levetiracetam tablets in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries and reflects experience over two decades [see Human Data] . In animal studies, levetiracetam produced developmental toxicity (increased embryofetal and offspring mortality, increased incidences of fetal structural abnormalities, decreased embryofetal and offspring growth, neurobehavioral alterations in offspring) at doses similar to human therapeutic doses [see Animal Data] .

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Levetiracetam Extended-Release (oral), Golden State Medical Supply, Inc. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Levels of levetiracetam in milk can be high in some women and can occasionally cause sedation and other adverse effects in their breastfed infants. If levetiracetam is required by the mother, it is not necessarily a reason to discontinue breastfeeding. However, the infant should be monitored for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of anticonvulsants. Maternal serum level monitoring and dosage adjustment is advisable in the early postpartum period if the drug was taken throughout pregnancy and breastfeeding.[1] Some evidence suggests that levetiracetam might reduce the maternal breastmilk supply in some women.

“Summary of Use during Lactation”, LactMed record “Levetiracetam” (LM362), quoted verbatim. Everything LactMed reports about Levetiracetam while breastfeeding.

8.2 Lactation Risk Summary Levetiracetam is excreted in human milk. There are no data on the effects of levetiracetam extended-release tablets on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Levetiracetam extended-release tablets and any potential adverse effects on the breastfed infant from Levetiracetam extended-release tablets or from the underlying maternal condition.

Prescribing label, section “8.2 Lactation”: Levetiracetam Extended-Release (oral), Golden State Medical Supply, Inc. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.