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Injured by Lamictal?

On September 29, 2006, the FDA notified healthcare professionals and patients of new information from the North American Antiepileptic Drug Pregnancy Registry signifying that babies exposed to Lamictal, designated to treat seizures and bipolar disorder, during the first three months of pregnancy might have a higher chance of being born with a cleft lip or cleft palate. Women who are pregnant and are taking Lamictal or who are thinking about taking this medication are strongly 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.

On August 8, 2006 drug manufacturer GlaxoSmithKline warned pregnant women of the potential association between the drug Lamictal (generic: lamotrigine) and cleft palate or cleft lip in newborns. Lamictal gained FDA (Food & Drug Association) approval in 1994 and was approved by Health Canada in 1995. Lamictal is prescribed to combat epilepsy.

Birth Defect Statistics
GlaxoSmithKline in conjunction with Health Canada stated that new statistics from a pregnancy registry recommend a correlation between taking Lamictal during the first trimester of pregnancy, and increased risk of cleft lip and/or palate in the baby. Based upon data from the public oral clefts is one of the most ordinary major birth defects, occurring at rates of 0.5 to 2.16 per 1,000 births. Data from the pregnancy registry illustrated three cases of cleft palate and two cases of cleft lip in infants born to 564 users Lamictal, a rate of 8.9 per 1,000.

Current patients taking Lamictal have been instructed to alert their doctors if they become pregnant or intend to become pregnant. Immediate stoppage of anti-eplieptic therapy may lead to breakthrough seizures with can cause serious risks for both the mother and the fetus and should be avoided. Peter Schram, a spokesman for GlaxoSmithKline, said other discontinuation symptoms could include rashes, dizziness, headaches, nausea and blurred vision.

Free Legal Evaluation
If you or a loved one has taken Lamictal while pregnant and you infant was born with a birth defect, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.