FDA Issues Safety Alert For Pregnant Women Taking Epilepsy Drug Lamictal

Main Category: Pregnancy / Obstetrics
Also Included In: Epilepsy;  Women's Health / Gynecology
Article Date: 05 Oct 2006 - 9:00 PDT

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FDA recently issued a safety alert saying that women taking GlaxoSmithKline's drug Lamictal -- which is used to treat epilepsy and bipolar disorder -- during the first three months of pregnancy might cause a cleft palate or lip to develop in the fetus, the Wall Street Journal reports. GSK in August after a discussion with Health Canada said it voluntarily informed physicians there was an "elevated rate" of cleft palate malformation in infants born to women who took Lamictal during the first three months of pregnancy, compared with women who were not taking the drug. A GSK spokesperson said that the drug has an established safety and efficacy record and that physicians would have to make decisions based on the patient (Wall Street Journal, 10/2).

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