Obstetrics and Gynecology

FDA Warns of Cleft Lip or Palate in Newborns with Topiramate

The FDA notified healthcare professionals and patients that topiramate (Topamax; Ortho-McNeil) is now being placed in Pregnancy Category D after new human data showed an increased risk of development of cleft lip and/or cleft palate in infants born to women treated with topiramate during pregnancy.