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VIVUS Inc. Message Board

  • sh0rtmimi sh0rtmimi Nov 2, 2010 6:53 AM Flag

    Qnexa is no teratogen. Topiramante selling since 15 years, NO EVIDENCE OF TERATOGENICITY

    Listen to the first minutes of conference call:
    http://ir.vivus.com/eventdetail.cfm?eventid=87873

    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.

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    • Bashers are grasping at straws here.

      Shorts are going to be destroyed very soon.

    • From the Qnexa AC transcript:

      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.

    • So much to birth defect concerns. Very small to non-existent. And heart beat even slowed at night. The FDA clearly wants to approve this drug.

 
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