"The FDA sent out a warning letter back in March, changing Topamax's category from Pregnancy Category C to Pregnancy Category D," Maldonado says. "What that means is that with a category C, there are no adequate studies in humans [that show a link between the drug and birth defects]. When it goes to category D, it means they do have controlled studies involving humans that show a risk of birth defects. So it is a big deal when they change a drug from category C to category D."
The change in category was announced after the FDA reviewed data obtained from the North American Antiepileptic Drug (AED) Pregnancy Registry, which suggested an increased risk of cleft lip and cleft palate in infants who were exposed to Topamax during the early stages of pregnancy. According to data obtained from the registry, infants exposed to topiramate (the generic equivalent of Topamax) during the first trimester experienced a 1.4 percent prevalence of oral clefts, compared with infants who were not exposed to any antiepileptic medications showing a 0.07 percent prevalence of oral clefts.
Although oral clefts can often be treated with surgery, families who have infants with oral clefts—which include cleft lip and/or cleft palate—are still advised to contact an attorney to discuss their legal options.
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Mothers who took Topamax while pregnant and gave birth to an infant with cleft lip or cleft palate are advised to speak with an attorney as soon as possible to determine their legal options.
"The biggest and most important thing to do is get this information to moms," Maldonado says. "Sometimes, the FDA mandates that the label be changed, but the doctors don't read their mail/emails, so the moms don't hear about the warning. We want to get this information to the moms."