Animal studies have shown administration during organogenesis increases embryofetal mortality and decreases fetal body weight in mice and rabbits. In rats, decreased pup survival, birth weight, and deficits in reflex development at doses also associated with maternal toxicity, were observed. Doses associated with these toxicities were generally less than the recommended human dose on a body surface area (mg/m2) basis. No data on exposed human pregnancies are available. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: 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 have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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: B3
US FDA pregnancy category: Not Assigned

Risk Summary: There are no adequate data on the developmental risks associated with use during pregnancy; animal data has shown evidence of developmental toxicity at maternal doses lower than the recommended clinical dose.

Comments:
-Based on indication, use during pregnancy and in women of childbearing potential is not expected
-A pregnancy registry is available to provide information on the effects of in utero exposure; pregnant patients should be 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: Yes

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.

This drug passes freely from plasma into milk in the goat. It is not expected that women with Dravet syndrome will breastfeed, however, if this occurs, the breast fed infant should be carefully monitored for potential adverse effects.

See references