1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC120
  



  

  
Submitter : 
  

  
Dr. Richard Wyatt
  

  
Date & Time: 
  

  
12/07/2006 11:12:24
  



  

  
Organization : 
  

  
Pioneer Valley Dermatology, p.c.
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I oppose the proposed restriction of hydroquinone-containing products.



I have been practicing dermatology since completing my residency in 1995. 

I use 4% hydroquinone regularly in my practice, prescribing it frequently each month.

I have NEVER seen a case of ochronosis from this; such an effect is well established, but very rarely seen in practice.



There is no better method of treating hyperpigmentation than hydroquinone.



There is also, to my knowledge, no reported case of hydroquinone induced skin cancer in humans. Restricting it because it is carcinogenic in humans when no such documentation exists seems a little over cautious to me, but when at the same time you plan to permit TriLuma, with 4% hydroquinone, to be used without apparent concern about carcinogenicity, the disparity of such a decision is highlighted, and raises questions on ethics or conflicts of interest--whether or not any such exist. If your panel really thought hydroquinone was carcinogenic, why would you allow a product containing it to be used??



Richard Wyatt

MD, PhD