Topamax is an anticonvulsant medication that is prescribed to treat epilepsy and the associated seizures, or can also be prescribed to prevent migraine headaches. Recently, the Food and Drug Administration (FDA) released a new warning about some birth defects associated with Topamax. Specifically, the drug warning states that mothers taking Topamax showed higher incidences of cleft lips and cleft palates than mothers not taking Topamax.
This discovery was made by the North American Antiepileptic Drug (NAAED) Pregnancy Registry, whose data showed that 1.4% of infants exposed to Topamax during the first trimester were likely to develop a cleft lip or cleft palate. The prevalence of cleft lips or palate in infants with no exposure to anticonvulsant medications was 0.07%.
In light of this new information, the FDA elevated the Topamax’s pregnancy category from C to D. Under Category D, “There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in
pregnant women despite potential risks.” Physicians are advised not to prescribe Topamax to pregnant women unless the potential benefits of the drug outweigh the potential risks to the fetus.