1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC116
  



  

  
Submitter : 
  

  
Dr. Arnold  Klein
  

  
Date & Time: 
  

  
12/07/2006 11:12:46
  



  

  
Organization : 
  

  
Professor of Dermatology UCLA
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I am writing to appeal to the FDA to leave hydroquinone available as OTC products and not require use by prescription. This would necessitate costly clinical trials for each hydroquinone agent and essentially make hydroquinone agents unavailable to the majority of users. Furthermore, the actual incidence of patients developing ochronosis is extremely low. Finally, there is absolutely no significant data which shows hydroquinone preparations to be carcinogenic. By removing these agents from the market as OTC preparations, this will cause hardship to the majority of users. I have used hydroquinone agents in my practice for many years and have never found there to be significant risk of adverse events or side effects. I would ask the FDA to use restraint in the goal of removing hydroquinones as OTC products. This is not scientifically sound policy.



Sincerely,



Arnold W. Klein, MD

Professor of Medicine and Dermatology

David Geffen School of Medicine at UCLA