Benefit should outweigh risk

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: There is limited amount of data on use in pregnant women and no adequate data on the developmental risks associated with use of this drug in pregnant women; based on animal data, may cause fetal harm.

Comments:
-Women of childbearing potential should discuss family planning and contraception with their healthcare provider.
-Infants born to mothers receiving anti-epileptic drugs have 2 to 3 times the prevalence of malformations compared to the general population. There is an even greater risk with polytherapy; however, the extent to which the treatment and/or the underlying condition is responsible has not been elucidated.
-Discontinuation of anti-epileptic drugs may result in exacerbation of the disease which could be harmful to the mother and the fetus.

Animal studies did not detect teratogenicity in the rat or rabbit. Developmental toxicity has been observed in animal studies (increased embryofetal mortality and decreased fetal body weights in rabbits; decreased growth, delayed sexual maturation, and long-term neurobehavioral changes in rat offspring) at doses greater than expected clinical exposure. This drug appears to readily cross the placenta in pregnant rats, however, there are no data on human placental transfer. There are no adequate and well controlled studies in human pregnancy.

For patients taking antiepileptic drugs during pregnancy, physician/patients should be encouraged to enroll patients in pregnancy registries to monitor pregnancy outcomes:
-North American Antiepileptic Drug (NAAED) Pregnancy Registry; Phone:1-888-233-2334; Website: http://www.aedpregnancyregistry.org/
-Australian Pregnancy Register for Women on Antiepileptic Medication with Epilepsy and Allied Conditions; Phone: 1800 069 722

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.

See references

Because women on antiepileptic drug (AED) therapy are often on a combination of anticonvulsants and these drugs are known to affect the metabolism of each, the relationship of maternal dose to the concentration in breastmilk can be quite variable. In published reports, 3 infants, including 1 set of twins, were breastfed while their mothers were taking this drug. The twins were partially breastfed twice a day by a mother on monotherapy, and the other infant was exclusively breastfed by a mother taking this drug, lacosamide and perampanel for 6 weeks, then partially breastfed. None of the infants exhibited reduced wakefulness or feeding problems. At one year of age, the mothers reported normal development.

Benefit should outweigh risk

Excreted into human milk: Yes
Excreted into animal milk: Yes

Comments:
-Limited information indicates that exclusively breastfed infants might have serum levels in the therapeutic range, but those who are partially breastfed may have undetectable levels.
-Some authorities believe discontinuing breastfeeding is not necessary with increased monitoring for drowsiness, agitation, adequate weight gain, and developmental milestones; if toxicity is suspected, infant serum should be measured.
-Some authorities advise against breastfeeding during therapy.

See references