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U.S. Department of Health and Human Services

Safety

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Lamictal (lamotrigine)

Audience: Neurologists, obstetricians, other healthcare professionals, and patients
[Posted 09/29/2006] The FDA notified healthcare professionals and patients of new preliminary information from the North American Antiepileptic Drug Pregnancy Registry that suggests that babies exposed to Lamictal, indicated to treat seizures and bipolar disorder, during the first three months of pregnancy may have a higher chance of being born with a cleft lip or cleft palate. More research is needed to be sure about the possibility of the increased chance of cleft lip or cleft palate developing in babies of pregnant women who take Lamictal. Women who take Lamictal and are pregnant or are thinking of becoming pregnant should talk with their doctor. Patients should not start or stop using Lamictal without talking to their doctor.

[September 28, 2006 - Patient Information Sheet - FDA]
[September 28, 2006 - Healthcare Professional Sheet - FDA]