1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC158
  



  

  
Submitter : 
  

  
Dr. Walter  Wood, MD
  

  
Date & Time: 
  

  
12/19/2006 09:12:38
  



  

  
Organization : 
  

  
American Academy of Dermatology
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Dear Sirs:



Hydroquinone has been used for many years in both prescription and OTC products for cutaneous hyperpigmentation.    Over these many years it has been observed by practicing dermatologists to be both safe and effective -- as a dermatologist I have seen only a few cases of exogenous ochronosis in my entire career -- and these were presented at regional meetings where rare conditions are presented.   Incidence of skin cancer in patients using hydroquinone creams has also not been observed to be any higher than in patients who do not use these products.   Also, there is inconsistency in that FDA has approved a prescription cream, Triluma (TM) which contains hydroquinone -- this product is little different than other formulations that have been in use for many years, except for its high price.   



It is my expert opinion that in view of the very long history of safe and effective use of hydroquinone, there NO justification at all for FDA intervention in the traditional uses of hydroquinone for skin hyperpigmentation disorders.



Walter Wood, MD, FAAD

fellow of the American Academy of Dermatology