2006P-0209
  

  
 Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  
Submitter : 
  

  
Mr. D Lowe
  

  
Date & Time: 
  

  
06/27/2006 11:06:44
  



  

  
Organization : 
  

  
Mr. D Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I oppose the petition. The safety and effiacy of Diastat is direct linked to Valium, which has the same active ingredient marketed for numerous conditions (attachment), and still available. Those were previously big 'V's in a tablet for chest pain, and also called 'Mother's Little Helper' in an old Rolling Stone's song. Misbrand all diazepam based products.



You can stop a seizure due to epilepsy soon after it happens with a possible rectal supposotory that requires a syringe and may be cracked? No one has ever had a breakthrough grand mal seizure I suspect. Teva's misbranded Klonopin which has no clinical investigations supposedly helps that. After 13 years, it's nice to know that's a CIV.



I oppose the petition. Two diazepam products for numerous conditions fail to disclose this from a website, labeling, and FDA is failing to inform the entire country. Diazepam is not safe for use, and a clinical trial would be nice to attach on Valium. I can't attach what doesn't exist.

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
2006P-0209-EC1-Attach-1.PDF