A preliminary analysis of data from the North American Antiepileptic Drug Pregnancy Registry suggests that fetuses exposed to lamotrigine (Lamictal) during the first 3 months of pregnancy may have a higher chance of being born with a cleft lip or cleft palate. The FDA notes that other pregnancy registries of a similar size haven't replicated this observation, and the organization cautions that the validity of this possible association can't be established until further data are collected. Lamotrigine is indicated for the treatment of seizures and bipolar disorder.

The FDA urges women who are pregnant and taking lamotrigine or who are thinking about taking this medication not to start or stop taking the medication without first consulting their healthcare provider. The agency states that more research is needed to be certain about the possibility of the increased chance of cleft lip or cleft palate developing in babies of pregnant women who take lamotrigine.

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