Focale Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women.
Postmarketing data from several prospective pregnancy registries have documented outcomes in over 1,000 women exposed to levetiracetam monotherapy during the first trimester of pregnancy.
Overall, these data do not suggest a substantial increase in the risk for major congenital malformations, although it indicates that the risk of having a child with a birth defect is greater for women on antiepileptic polytherapy, including levetiracetam as a component, than for women not treated with AEDs. Therapy with multiple AEDs is associated with a higher risk of congenital malformations than monotherapy and therefore monotherapy should be considered.
Levetiracetam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Discontinuation of antiepileptic treatments may result in disease worsening, which can be harmful to the mother and the fetus.
As with other AEDs, physiological changes during pregnancy may affect levetiracetam concentration. There have been reports of decreased levetiracetam concentrations during pregnancy. This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy). It is recommended that clinical response should be monitored carefully in women receiving levetiracetam treatment during pregnancy, and determination of changes in plasma concentrations should be considered to ensure that adequate seizure control is maintained throughout pregnancy. In the event that medication is increased during pregnancy, the dose may need to be adjusted postpartum.
The risk of having teratogenic effects as a result of antiepileptic medication is far outweighed by the dangers to the mother and fetus of uncontrolled epilepsy. It is recommended that: Women on AEDs receive pre-pregnancy counseling with regard to the risk of fetal abnormalities; AEDs should be continued during pregnancy and monotherapy should be used if possible at the lowest effective dose as risk of abnormality is greater in women taking combined medication; Folic acid supplementation (5 mg) should be commenced four weeks prior to and continue for 12 weeks after conception; Specialist prenatal diagnosis including detailed mid-trimester ultrasound should be offered.
Fertility: There are no human data on the effects of levetiracetam on male or female fertility.
Labor and Delivery: The effect of levetiracetam on labor and delivery is unknown.
Lactation: Levetiracetam is excreted in human breast milk. A decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into consideration the importance of the drug to the mother, because of the potential for serious adverse reactions in breastfeeding infants from levetiracetam.