Since the July 2010 FDA advisory committee meeting to review the original NDA for Qnexa phentermine/topiramate from Vivus Inc. (NASDAQ:VVUS), there have been three studies conducted to assess the teratogenic potential of the topiramate component with respect to oral clefts and major congenital malformations (MCMs). The ratios for oral cleft ranged from 1.47-5.36, indicating up to a 5X increase