General Risk Associated with Epilepsy and Antiepileptic Drugs: The rate of malformations in the offspring of women with epilepsy has been shown to be 2-3 times higher than the rate of about 3% found in the general population. In treated women, an increase in malformations was primarily found in those given combination therapy. It was not possible to determine to what extent the specific treatment and/or the disease was responsible for this.
In addition, effective antiepileptic therapy should not be interrupted as aggravation of the disease is detrimental to both the mother and the fetus.
Risk Related to Oxcarbazepine: Data on administration in pregnant women are limited.
In animal studies, increased embryo mortality, delayed growth and malformations were observed with high maternally toxic doses (see Toxicology under Actions).
If a woman receiving Trileptal becomes pregnant or plans to become pregnant, or if Trileptal needs to be initiated during pregnancy, the need for Trileptal therapy must be reconsidered. This is particularly important during the first 3 months of pregnancy. The lowest effective dose should be given. In women of childbearing age, Trileptal should be given as monotherapy whenever possible and at least during the first 3 months of pregnancy. Patients should be counselled regarding the possibility of an increased risk of malformations and given the opportunity of antenatal screening.
Effective antiepileptic therapy with oxcarbazepine must not be interrupted during pregnancy as aggravation of the disease is detrimental to both the mother and fetus.
Monitoring and Prevention: Folic acid deficiency may occur during pregnancy. Antiepileptics have been reported to aggravate this condition. Folic acid deficiency can contribute to an increased incidence of fetal malformations. Folic acid supplementation is therefore recommended before and during pregnancy.
Vitamin B12 deficiency should be ruled out or treated.
Lactation: Oxcarbazepine and its active metabolite MHD are excreted in breast milk.
Effects on the infant exposed to Trileptal are unknown. For this reason, Trileptal should not be given to women who are breastfeeding.