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Lamictal (Lamotrigine) - Exposure to Medication During the First 3 Months of Pregnancy May Increase Chances of Baby Being Born With Cleft Lip or Cleft Palate
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
BETHESDA, MD -- September 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 (lamotrigine), indicated to treat seizures and bipolar disorder, during the first 3 months of pregnancy may have a higher chance of being born with a cleft lip or cleft palate.
Women who are pregnant and taking Lamictal or who are thinking about taking this medication are urged to not start or stop taking the medication without first talking to their physician. 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.
SOURCE: Food and Drug Administration
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