Use in pregnancy: Post-marketing data from several prospective pregnancy registries have documented outcomes in over 2000 women exposed to Lamictal monotherapy during the 1st trimester of pregnancy. Overall, these data do not suggest a substantial increase in the risk for major congenital malformations, although data from a limited number of registries have reported an increase in the risk of isolated oral cleft malformations. A case control study did not demonstrate an increased risk of oral clefts compared to other defects following exposure to lamotrigine. The data on use of Lamictal in polytherapy combinations are insufficient to assess whether the risk of malformation associated with other agents is affected by concomitant Lamictal use.
As with other medicines, Lamictal should only be used during pregnancy if the expected benefits outweigh the potential risks.
Physiological changes during pregnancy may affect lamotrigine levels and/or therapeutic effect. There have been reports of decreased lamotrigine levels during pregnancy. Appropriate clinical management of pregnant women during Lamictal therapy should be ensured.
Use in lactation: Lamotrigine has been reported to pass into breast milk in highly variable concentrations, resulting in total lamotrigine levels in infants of up to approximately 50% of the mother's. Therefore, in some breastfed infants, serum concentrations of lamotrigine may reach levels at which pharmacological effects occur.
The potential benefits of breastfeeding should be weighed against the potential risk of adverse effects occurring in the infant.