March 04, 2011
FDA Warns of Cleft Lip or Palate in Newborns with TopiramateThe 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.
The FDA recommends that the benefits and the risks of topiramate be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death. Women of childbearing age should be informed of the increased risk for oral clefts when topiramate is used in the first trimester of pregnancy. Healthcare professionals should recommend use of effective contraception for women who are not planning a pregnancy, keeping in mind the potential for a decrease in hormonal exposure and a possible decrease in contraceptive efficacy when using estrogen-containing birth control with topiramate.
Topiramate is indicated for the treatment of partial-onset or primary generalized tonic-clonic seizures, and as an adjunct in Lennox-Gastaut syndrome. Topiramate is also indicated for migraine prophylaxis.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245777.htm.