Topiramante selling since 15 years at least at 4x higher doses than in Qnexa and there has been not even an evidence that Topiramante got teratogen signal. Furthermore adittional data from teratogenesis experts will be part of resubmission to answer all concerns raised at Adcom panel.
Human pregnancies' exposures to antiepileptic drugs have been monitored by several pregnancy registries, some of which include the United Kingdom Epilepsy and Pregnancy Register. In 2008, this group published information regarding outcomes of pregnancy exposed to topiramate. Of 70 topiramate monotherapy-exposed pregnancies, there were three major malformations, for a calculated malformation rate of 4.8 percent. Two of the malformations were oral cleft abnormalities at 200 milligrams per day and 16 600 milligram per day.
In conclusion, it is a concern that there appears to be a repeated pattern of craniofacial congenital malformation observed in animal studies, separate pregnancy registries in the United Kingdom and North America, and within the FDA AERS database.
Not to mention that a lot of women aren't going to like the much increased risk of getting pregnant in the first place, even with the risk of birth defects.