The FDA issued a “Drug Safety Communication” regarding the risk of oral clefts in children born to mothers taking Topomax (topiramate) in March 2011. It outlined the risks and said women of childbearing age should use effective birth control while taking Topomax or discuss the use of Topomax with their doctors if they become pregnant or plan to become pregnant.
The FDA said healthcare professionals should inform women of childbearing age of the increased risk for oral clefts when topiramate is used in the first trimester of pregnancy. Doctors should weigh the benefits and risks of topiramate when prescribing it to women of childbearing age and consider alternatives or, if they prescribe Topomax, should explain that the North American Antiepileptic Drug (NAAED) Pregnancy Registry reported a risk of oral cleft in babies born to mothers who took Topomax.
The position of the FDA as of its March 2011 advisory is that the potential benefits from use of Topomax (topiramate) by pregnant women may be acceptable in certain situations despite the risks.