1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC159
  



  

  
Submitter : 
  

  
Dr. Amy McMichael
  

  
Date & Time: 
  

  
12/20/2006 08:12:04
  



  

  
Organization : 
  

  
Assoc Prof Derm, Wake Forest Univ Sch of Med
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Hydroquinone is one of the most effective molecules for the treatment of dark discoloration over the past 40-50 years and has been used in millions of people. It is used to treat the top concerns among our patients including melasma, photo-aging, post-inflammatory hyperpigmentation, medically and cosmetic disfiguring dyschromias.



Since 1961, hydroquinone has demonstrated a safe and effect profile among clinicians prescribing or recommending hydroquinone products. In spite of humans exposure to natural sources of hydroquinone in wheat, pears, berries, coffee, tea, onions, rice and red wine, there is not an association with carcinogenicity.  There have been no reported cases of related malignancies in more than 50 years of manufacture and use of HQ.



Moreover, this medication is used preferentially in patients with skin of color.  This suggests that the removal of the product can have a more negative effect on minority groups, making removal a potentially baised decision as minority women will be more negatively impacted than other ethnic groups.

  

Preliminary data analysis of a well-known data base (National Ambulatory Medical Care Survey data base from 1998-2004) shows that that hydroquinone is used preferentially by minority women. It would be a travesty to remove a product that is so necessary in the treatment of skin disease in all populations, but particularly in the minority population, without compelling data of true risk.  



Please rethink the potentially racially biased and medically unsound position of hydroquinone removal from the market.