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FDA is alerting health care professionals and patients that infants exposed to Lamictal (lamotrigine) during the first trimester of pregnancy may have an increased risk of being born with a cleft lip or palate. Lamictal is used to treat certain patients with seizures or bipolar disorder. FDA's caution was based on preliminary data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry. In this particular registry, the prevalence of cleft lip and palate if the mother took Lamictal was about 9/1000. That compares with about 0.5/1000 to 2/1000 in other studies that looked at non-epileptic women not taking the drug. Although cleft lip and palate are often part of a broader syndrome that includes other congenital anomalies, the defects in this registry were not part of a larger syndrome. Also, the increased prevalence of cleft lip and palate hasn't been seen in other pregnancy registries of similar size, so the clinical significance of these findings is still uncertain. FDA has identified several points that practitioners should take into account when they consider prescribing Lamictal during pregnancy. First, if the epilepsy or bipolar disorder isn't treated, this can expose the woman and her unborn child to significant health risks. These risks have to be weighed against the risks of taking Lamictal, one of which may be an increased risk of cleft lip and palate, although this remains unconfirmed at this point. The number of pregnant women in the NAAED and other pregnancy registries exposed to several of the other new antiepileptic drugs is too small to establish an estimate of comparative risk among the newer antiepileptic drugs. Patients need to know that seizures and bipolar disorder are serious conditions that continue to need treatment during pregnancy. FDA advises women who take Lamictal and are pregnant or are thinking of becoming pregnant to talk to their physicians. And physicians should warn patients to consult with them before they start or stop using the drug.

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