If your child has a cleft lip and you took Lamictal during your pregnancy, please contact us immediately. On September 28, 2006, the U.S. Food and Drug Administration put out an official alert to consumers about a drug called Lamotrigine (marketed as “Lamictal”). Manufactured by GlaxoSmithKline, Lamictal is the first FDA-approved medication for the long-term treatment of adults with bipolar disorder since Lithium was approved in 1970.
Patients diagnosed with bipolar disorder suffer either mania or depression that can last days, weeks, or even months. Lamictal, which came onto the market in 1994 was designed to increase the time between episodes. Recently, Lamictal was also approved to treat the most serious forms of epileptic seizures — Primary Generalized Tonic-Clonic seizures, better known as “grand mal.”
Preliminary data from the North American Antiepileptic Drug Pregnancy Registry, however, suggest a possible association between exposure to Lamictal monotherapy during the first trimester of pregnancy and cleft lip and/or cleft palate.
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