2006P-0405
  

  
 Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7
  



  

  
Submitter : 
  

  
Ms. Kathy Braden
  

  
Date & Time: 
  

  
04/03/2007 06:04:30
  



  

  
Organization : 
  

  
Children's Epilepsy Center
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I am a neurophysiology social worker employed at an Atlanta Children's Hospital, working with children diagnosed with intractable seizures. These are the kids who dont respond to traditional medication regimes. I have seen how medication themselves can create an inability to function, cognitive and mood/behavior problems in and of themselves--but the damage from seizures are worse. These anti-convulsive meds are tricky. Those available have been well researched. I have seen countless times how the generic versions, once available, dont offer the same level of effectiveness/seizure control. FDA needs to protect our kids and ensure generics are as close to the"original" as can be AND warn those working with the meds,parents of the children effected by the meds and docs prescribing the DANGERS of non-identical substitutes!!!Kathy Braden, LCSW 404-785-3034