1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC109
  



  

  
Submitter : 
  

  
Dr. Anna Guanche
  

  
Date & Time: 
  

  
12/07/2006 11:12:31
  



  

  
Organization : 
  

  
Bella Skin Institute
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Hydroquinone has been used for over 50 years as a prescription drug and as an otc drug at lower percentages.  This is obviously a cosmeceutical company ploy to remove competition.  The truth is, no drug is more effective at reducing unwanted pigment, and exogenous ochronosis is incredibly rare. If it does occur, most times it is reversible, and even if not, is not life-threatening. Carcinogenesis?  Where is the proof?  What was the inciting factor that suddenly struck the heads of the FDA about this drug?  After 50 or more years of widespread use, someone has brought to light the "possible carcinogenesis" statement that is on almost every drug that is ingested in gargantuan doses.  If we start gulping down hydroquinone, then there is a problem.  I think the motives underlying this quest to remove HQ from the market should be investigated.  Plus, Galderma did FDA-approved safety studies on Tri Luma, a topical that contains 4% HQ and did not see problems.  How could that logic follow?



Anna D Guanche, MD

Fellow, American Board of Dermatology