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In studies Topamax caused birth defects, miscarriages, and low fetal weight when given to pregnant rabbits and mice. When Topamax was given to pregnant women, it also caused some oral cleft birth defects.
The Food & Drug Administration applies A, B, C, D, and X categories to different prescription drugs for pregnant women.
Some drugs approved by FDA that are safe and effective for use by non-pregnant women may pose added risks to pregnant women and their infants. The FDA assigns all approved drugs to a pregnancy category based on data obtained from animal studies, clinical studies, or experience.
Drugs in Pregnancy Category C are designated for medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies. Drugs in the Pregnancy Category D have human data presenting evidence of human fetal risk, but the potential benefits of these drugs may still be considered acceptable in certain situations.
Topamax and its generic, topiramate were in Pregnancy Category C when released in the pharmaceutical marketplace.
FDA received new data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry which show an increased risk for cleft lip and/or cleft palate in infants exposed to Topamax and topiramate during the first trimester of pregnancy. After receiving this important new data, the FDA reclassified Topamax and topiramate as Pregnancy Category D.