2006P-0405
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  
Submitter : 
  

  
Ms. Julie Denton
  

  
Date & Time: 
  

  
04/03/2007 06:04:17
  



  

  
Organization : 
  

  
Kentucky General Assembly
  



  

  
Category : 
  

  
State Government
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 FDA's Division of Dockets Management

Reference:  Docket # 2006P-0405



To whom it may concern:



I am writing to express my support for Section 1 and 2 of the Actions Requested Section (Part I) of the UCB Citzen Petition.



Section 1 of Part I would require that the full prescribing information of all new and existing antiepileptic drugs (both branded and generic) include a new warning stating that physicians and pharmacists should exercise extreme caution when switching patients who are seizure free or whose seizures are well controlled.



As you now, the goal of antepileptic drug therapy is seizure freedon with minimal side effects.  One breakthrough seizure can cause significant disruptions in a patient's life, including loss of legal privileges, severe injury or even death.  I support the Citizen's Petition goal of enacting measures which could help prevent these issues from happening in seizure free and well controlled patients with epilepsy.  It is also noteworthy that the petition is not confined to a single drug, but the entire class of AEDs.



Thank you for the opportunity to expresss my support of the Citizen Petition.



Sincerely,



Senator Julie Denton

Chair, Senate Health & Welfare Committee

Kentucky State Senate