1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC138
  



  

  
Submitter : 
  

  
Dr. David South
  

  
Date & Time: 
  

  
12/12/2006 09:12:46
  



  

  
Organization : 
  

  
American Academy of Dermatology
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Dear FDA Representative:

The preposed restriction on prescription hydroquinone is both punative and unnecessary.  Adverse reactions are extremely rare when used in the standard 3-4% concentration.  By contrast, this is one of the most appreciated medications available to those who are devastated by their hyperpigmentation (in our extremely cosmetically oriented society).



There is absolutely no evidence of carcinogenicity in humans in over 50 years of use worldwide, by millions of patients. 



In 28 years of practice I have never talked to one dermatologist that has personally encountered a problem (other than mild irritation) in any patient using hydroquinone in a clinically monitered setting.



Please do not remove this very valuable tool, for which there is no substitute on the basis of an unsubtantiated and unconfirmed study in rodents. 



Sincerely,  David A. South, M.D.