1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC132
  



  

  
Submitter : 
  

  
Dr. Kenneth Warrick
  

  
Date & Time: 
  

  
12/08/2006 08:12:01
  



  

  
Organization : 
  

  
Dorn VA Medical Center
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Many of my patients with mild to moderate hyperpigmentation use the OTC hydroquinone products with good results.  I typically only see those that fail to receive clearance of the pigment.  I have only seen one case of suspected ochronosis in my 31 year dermatology career to date (50,000+ patients, 200,000+ office visits--most in sunny South Carolina).  Hispanics, African Americans, and near-Eastern persons are most susceptible. Facial appearance is extremely important to the psychological sense of well-being to these people.  Many of them are in lower socioeconomic groups who can ill afford doctor visits and prescription medications.  Due to aggravation of facial dyspigmentation, many women will not take estrogen-containing oral contraceptives, thus adding the cost of raising additional children.



Removing hydroquinone from the OTC market for the rare cases of ochronosis would be a heartless action.