FDA Alert: Topiramate Increases Risk for Birth Defects

Because of a topiramate-associated risk for oral clefts, the FDA has now designated topiramate as a pregnancy category D drug.

On March 4, 2011, the FDA reported an increased risk for oral clefts in infants born to women taking topiramate during pregnancy.

Data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry revealed that mothers taking topiramate during the first trimester of pregnancy had an increased risk for infants born with oral cleft palate or lip. According to the registry data, 1.4% of infants exposed to topiramate in utero were born with a cleft lip or palate, compared with a range of 0.38% to 0.55% of infants born to mothers taking other antiepileptic medications during pregnancy and with 0.07% of infants born to mothers who neither had epilepsy nor took antiepileptic medications.

Topiramate has now been designated as a category D dru…

Authors

Ana Recober, MD

Rashmi Halker, MD