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Antiepileptic drug (AED) exposure during pregnancy is associated with an increased rate of major congenital malformations (MCMs): 4% to 9%, compared to 1% to 2% in the general population. The risk is even greater with use of valproate and with polytherapy. This is the first report of prospectively collected birth-outcome data with topiramate. The study was partially industry-supported.
Of 178 live births reported following exposure to topiramate in the first trimester, 62 were exposed to topiramate monotherapy and 116 to topiramate polytherapy. Among the live births, MCM rates were 4.8% (95% confidence interval, 1.7%–13.3%) in the monotherapy group and 11.2% (95% CI, 6.7%–18.2%) in the polytherapy group. Notably, in the total group, oral cle…