Lamictal Birth Defects Reported to the FDA. In September 2011, AdverseEvents, Inc. reported that its analysis of the FDA’s Adverse Event Reporting System (AERS) indicated that Lamictal was more dangerous to unborn babies than previously thought. The analysis indicated that moving Lamictal from its current FDA pregnancy risk class, Category C (“no known human risk”), to Category D (“positive evidence of human fetal risk”) could be warranted.
In conducting its analysis, AdverseEvents used a proprietary process called RxFilter to analyze the FDA’s AERS database for treatment-related birth defects, stillbirths and congenital abnormalities potentially associated with 18 anti-epilepsy medications, including Lamictal, that are commonly prescribed during pregnancy. The time period covered by the AdverseEvents analysis was January 1, 2004 to March 31, 2011.
Lamictal Birth Defects Reported : Babies exposed to Lamictal during the first three months of pregnancy might have a higher chance of being born with a cleft lip or cleft palate
According to AdverseEvents, an average birth defect rate comparison between Lamictal and top Category D drugs yielded a surprising result; no meaningful differences were found. “These results indicate that regulatory bodies may want to consider category shifts for some of the most widely used antiepilepsy medications. Prospective studies, however, are needed to establish the exact incidence of these adverse events and to determine appropriate changes in category labeling, if any. This analysis warrants the attention of all healthcare providers and patients associated with epilepsy medications,” a statement from AdverseEvents said.
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.
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.