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Heightened risks for orofacial cleft and clubfoot have been reported with first-trimester exposure to lamotrigine. To investigate these risks further, investigators in a manufacturer-funded study analyzed data from a network of 21 European registries involving 10.1 million births from 1995 to 2011; the authors had previously linked lamotrigine to clubfoot in this network.
The overall rate of major malformations was 2.25%. There were 147 babies with nonchromosomal congenital anomalies (NCA) and exposure to lamotrigine monotherapy in the first trimester. The investigators examined rates of first-trimester exposure to lamotrigine monotherapy in babies with orofacial cleft or clubfoot and in those with other NCA. Analyses were adjusted for mater…