Does lamotrigine use in pregnancy increase orofacial cleft risk relative to other malformations

摘要: Objective: To investigate whether first trimester exposure to lamotrigine (LTG) monotherapy is specifically associated with an increased risk of orofacial clefts (OCs) relative other malformations, in response a signal regarding OC risk.Methods: Population-based case-control study malformed controls based on EUROCAT congenital anomaly registers. The population covered 3.9 million births from 19 registries 1995–2005. Registrations included among livebirths, stillbirths, and terminations pregnancy following prenatal diagnosis. Cases were 5,511 nonsyndromic registrations, whom 4,571 isolated, 1,969 cleft palate (CP), 1,532 isolated CP. Controls 80,052 nonchromosomal, non-OC registrations. We compared LTG antiepileptic drug (AED) use vs nonepileptic non-AED use, for mono polytherapy, adjusting maternal age. An additional exploratory analysis the observed expected distribution malformation types use.Results: There 72 exposed (40 mono- 32 polytherapy) ORs no AED 0.67 (95% CI 0.10–2.34) 0.80 0.11–2.85) OC, 0.79 0.03–4.35) CP, 1.01 0.03–5.57) any 1.43 1.03–1.93) 1.21 0.82–1.72) 2.37 1.54–3.43) 1.86 1.07–2.94) nonchromosomal was similar exposed.Conclusion: find evidence specific malformations due monotherapy. Our not designed assess there generalized exposure.Neurology® 2008;71:714–722