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The teratogenic potential of anticonvulsant medications is well known to pediatricians. However, limited data are available on the teratogenicity of newer anticonvulsants, including topiramate, a sulfamate-substituted monosaccharide that is prescribed for generalized tonic-clonic or partial seizures and was approved by the FDA in 2004 for migraine prophylaxis.
Investigators in the U.K. prospectively followed 203 pregnant women with epilepsy who were taking topiramate when they became pregnant. Among 178 live births, 16 newborns (9.0%) had major congenital malformations. Major malformation occurred in 3 of 62 infants (4.8%) who had been exposed to topiramate as monotherapy (mean dose, 400 mg) and in 13 of 116 infants (11.2%) who had been expo…