Topamax Warning? The Food and Drug Administration issued a "Drug Safety Communication" notifying the public of new evidence demonstrating increased risk for the development of oral birth defects in infants born to women who took Topamax (Topiramate) during pregnancy.
2. The benefits and risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death. Alternative medications that have lower risk of oral clefts and other adverse birth outcomes should be considered for these patients. If decision is made to use topiramate in women of childbearing age, effective birth control should be used. Oral clefts occur in the first trimester of pregnancy before many women know they are pregnant.