Developmental toxicities have been observed in animal studies. In rats, increased embryofetal mortality occurred at 16 and 9 times the recommended human dose of 20 and 25 mg/kg/day, respectively. In rabbits, decreased fetal body weights and and increased fetal structural variations associated with maternal toxicity occurred at maternal plasma exposures similar to the recommended human dose. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Benefit should outweigh risk

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Risk Summary: There are no adequate data on the developmental risks associated with use in pregnant women; based on animal data, exposure may cause fetal harm.

Comments:
-A pregnancy registry is available that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AED) including this drug. Women receiving this drug during pregnancy are encouraged to enroll: North American AED Pregnancy Registry: US toll free number: 1-888-233-2334; Website: http://www.aedpregnancyregistry.org/

See references

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
-Some authorities recommend discontinuing breast feeding during treatment.

Cannabidiol is a component of cannabis and while cannabidiol has not been studied in lactating women, it has been detected in the breastmilk of some mothers who used cannabis products. Because no published information is available with it's use as an antiepileptic during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

See references