Lamotrix Use In Pregnancy & Lactation

Pregnancy: Administration of lamotrigine did not impair fertility in animal reproductive studies.
There is no experience of the effect of lamotrigine on human fertility.
Postmarketing data from several prospective pregnancy registries have documented outcomes in over 8,700 women exposed to lamotrigine monotherapy during the first trimester of pregnancy. These data do not exclude an increased risk for major congenital malformations. Although a number of registries have reported an increase in the risk of isolated oral cleft malformations, a completed case control study with 259 exposures to lamotrigine therapy did not demonstrate an increased risk of oral clefts compared to other major congenital malformations following exposure to lamotrigine. Animal studies have shown developmental toxicity. The data on use of lamotrigine in polytherapy combination are insufficient to assess whether the risk of malformations associated with other agents is affected by concomitant lamotrigine use.
As with other medicines, LAMOTRIX 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 LAMOTRIX therapy should be ensured.
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 breast feeding should be weighed against the potential risk of adverse effects occurring in the infant.