Why bother doing animal testing if the results are just going to be ignored? The FDA has just issued a warning that Topamax (topiramate), an anti-seizure medication that is one of the most widely prescribed migraine drugs, triples the risk of cleft lip and cleft palate birth defects. Oral clefts, as they are collectively called, are a deformation that happens in the first trimester of pregnancy when many women may not even realize they are pregnant.
Even though earlier animal studies had shown that Topamax significantly increases the risk of such birth defects, the FDA had kept the drug in Pregnancy Category C, which is intended to indicate to doctors that “potential benefits may warrant use of the drug in pregnant women despite potential risks.” That category has now been shown to be inadequate to warn women, and their doctors, of the dangers of Topamax use.
Based on the evidence, the FDA has been forced to reclassify topiramate as a Pregnancy Category D drug, which means doctors have to carefully weigh the risks and benefits of the drug before prescribing it to treat epilepsy seizures or migraines, because there is a high association with birth defects. With "safer" anti-seizure and migraine alternatives available, and considering the window where it causes the defect, should Topomax be prescribed to women of child bearing age at all?
US FDA (2011). "FDA: Risk of oral birth defects in children born to mothers taking topiramate." FDA Press Release Published Online March 4, 2011.
