Antiepileptic medication warning for pregnant women: TGA

Topiramate has been moved from Category B3 to Category D, the category for drugs which “have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage”. 

Last year the US Food and Drug Administration received new data showing an increased risk for oral cleft and/or palate in infants exposed to topiramate during the first trimester of pregnancy.

Prescribers should advise women of childbearing age about the risk, the TGA said.

Medicines Safety Update 2012; 35:66