The Pharmaceutical Journal
Vol 276 No 7406 p743
24 June 2006

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Concerns over oral clefts with lamotrigine use in pregnancy

Increased risk of oral clefts with use of lamotrigine (Lamictal) in early pregnancy has been highlighted this week in a letter from GlaxoSmithKline to health care professionals.

GSK has issued the notice in response to data from the North American Antiepileptic Drug Pregnancy Register that point to a greater incidence of oral cleft deformity in infants exposed to lamotrigine monotherapy during the first trimester of pregnancy.

The letter warns against the “sudden discontinuation of antiepileptic therapy [which] may lead to breakthrough seizures with serious consequences for both the mother and the fetus”.

The summary of product characteristics for Lamictal, which already contains a statement about prescribers needing to weigh the risks and benefits of using lamotrigine in pregnancy, will be updated with the new data.