Risk for Orofacial Cleft with Lamotrigine Use in Pregnancy

Despite postmarketing data suggesting a highly elevated risk for orofacial clefts associated with lamotrigine use, this case–control study found no such increase relative to the risks for other major malformations.

A recent analysis of data from the North American AED Pregnancy Registry suggested an unexpectedly high risk for orofacial clefts (OCs) in infants exposed to the antiepileptic drug (AED) lamotrigine (LTG) monotherapy during the first trimester of pregnancy. The finding raised concern among clinicians and patients and led to an FDA alert. In this multicenter, population-based, case–control analysis, researchers assessed whether exposure to LTG was associated specifically with an increased risk for OC relative to the risks for other major malformations.

Using the EUROCAT central database (a population-based register of congenital anomalies that accounts for one quarter of births in Europe), the researchers compared the odds of LTG exposure amo…

Reviewing Author

Ellen J. Bubrick, MD

Risk for Orofacial Cleft with Lamotrigine Use in Pregnancy

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Reviewing Author