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 : 
  

  
EC5
  



  

  
Submitter : 
  

  
Mr. Dave Lowe
  

  
Date & Time: 
  

  
06/27/2006 11:06:42
  



  

  
Organization : 
  

  
Mr. Dave Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I oppose the petition providing Safety or Efficacy to a rectal gel, and present Depacon for enforcement action. Labeling revised 01/06 misbrands the injection, see attachment. Withdraw any paper that may (or may not have) made that FDA approved. Adequete and well controlled clinical investigations should be the law.



THERE ARE MULTIPLE REPORTS IN THE CLINICAL

LITERATURE WHICH INDICATE THAT THE USE OF

ANTIEPILEPTIC DRUGS DURING PREGNANCY RESULTS IN AN

INCREASED INCIDENCE OF BIRTH DEFECTS IN THE

OFFSPRING. ALTHOUGH DATA ARE MORE EXTENSIVE WITH

RESPECT TO TRIMETHADIONE, PARAMETHADIONE,

PHENYTOIN, AND PHENOBARBITAL, REPORTS INDICATE A

POSSIBLE SIMILAR ASSOCIATION WITH THE USE OF OTHER

ANTIEPILEPTIC DRUGS. THEREFORE, ANTIEPILEPSY DRUGS

SHOULD BE ADMINISTERED TO WOMEN OF CHILDBEARING

POTENTIAL ONLY IF THEY ARE CLEARLY SHOWN TO BE

ESSENTIAL IN THE MANAGEMENT OF THEIR SEIZURES.

THE INCIDENCE OF NEURAL TUBE DEFECTS IN THE FETUS

MAY BE INCREASED IN MOTHERS RECEIVING VALPROATE

DURING THE FIRST TRIMESTER OF PREGNANCY. THE CENTERS

FOR DISEASE CONTROL (CDC) HAS ESTIMATED THE RISK OF

VALPROIC ACID EXPOSED WOMEN HAVING CHILDREN WITH

SPINA BIFIDA TO BE APPROXIMATELY 1 TO 2%.

Animal studies have demonstrated valproate-induced teratogenicity.

Increased frequencies of malformations, as well as intrauterine growth

retardation and death, have been observed in mice, rats, rabbits, and

monkeys following prenatal exposure to valproate. Malformations of the skeletal system are the most common structural abnormalities produced in experimental animals.(See WARNINGS and LOUD SIRENS)

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
2006P-0209-EC5-Attach-1.PDF