The US Food and Drug Administration reported in Sept’06 that preliminary information from the North American Antiepileptic Drug Pregnancy Registry suggested that babies exposed to Lamictal during the first three months of pregnancy may have a higher chance of being born with a cleft lip or cleft palate.
In this particular registry, the prevalence of cleft lip and palate if the mother took Lamictal was about 9/1000. That compares with about 0.5/1000 to 2/1000 in other studies that looked at non-epileptic women not taking the drug. The FDA stated that the clinical significance of the findings is still uncertain, and more research was 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.
GlaxoSmithKline (GSK) has sent an alert about its epilepsy drug Lamictal (generic name Lamotrigine) to medics and health care professionals all over the world.
While it has long been known that all anti epileptic drugs (AEDs) hold some dangers for mothers to be, Lamictal had been widely viewed as offering the best option for women of child bearing age. This may well still be true but this latest news does serve to point up the need for all women and girls with epilepsy to be very proactive about their condition and ideally should plan their pregnancies in a way that will minimise risk.
Any women currently taking Lamictal should continue to do so and should raise any concerns she has with her doctor, epilepsy specialist nurse or with Brainwave. Indeed for any woman on any AED the dangers posed by coming off your medication without consultation may far outweigh any risks to your baby.
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