FDA Warns of Risk of Oral Birth Defects in Children Born to Mothers Taking Topiramate Legal News Articles & Interviews

Washington, DC Data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to Topamax (topiramate) during the first trimester of pregnancy. Infants exposed to topiramate as a single therapy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent – 0.55 percent in infants exposed to other antiepileptic drugs.