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September 29, 2006
The U.S. Food and Drug Administration issued a Lamictal alert earlier this week, warning of the increased risk of birth defects when taken during the first trimester of pregnancy.
According to the FDA statement, babies exposed to the drug in the first three months of pregnancy may face a higher chance of being born with a serious defect such as a cleft lip or palate.
Lamictal is an antidepressant manufactured by GlaxoSmithKline and used in the treatment of patients with seizure disorders or bipolar disorder. The drug's labeling previously listed only less severe side effects, including headache, nausea, insomnia and others.
Other antidepressants, particularly Paxil and Prozac, have also been linked to birth defects when taken during pregnancy. The FDA now requires antidepressants to carry a heightened warning label, alerting patients to the risk of birth defects.
The notice issued by the FDA was based on preliminary findings, and the agency said more research is necessary to understand the extent of the risk.
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More Lamictal Resources
MedLine Plus Drug Information - Guide to prescription and over-the-counter medications provided by the United States Pharmacopeia.
Lamictal.com - Designed for healthcare professionals, this site contains comprehensive and recent information about Lamictal.