1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC550
  



  

  
Submitter : 
  

  
Dr. Pearl Grimes
  

  
Date & Time: 
  

  
12/28/2006 08:12:30
  



  

  
Organization : 
  

  
Dr. Pearl Grimes
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 The Food and Drug Administrations (FDA) review of skin-bleaching drug products for over-the-counter (OTC) human use (Docket No. 1978N- 0065) will remove from the market unapproved prescription and non prescription hydroquinone based skin bleaching products. 



Hydroquinone remains the most effective topical lightening agent approved for treatment of common hyperpigmentation disorders. These acquired disorders include melasma, postinflammatory hyperpigmentation, solar lentigines and the dyschromia of photoaging. Although not life threatening or physically debilitating, the cosmetic disfigurement caused by these disorders is psychologically devastating, with life-altering changes for the patients. In particular, melasma has been shown to have deleterious effects on quality of life. An improved quality of life has been reported with effective treatment of facial melasma. 



After 50 years of use of hydroquinone in the United States, it remains the most effective over the counter or prescription topical bleaching agent. Many patients with pigmentary disorders would suffer significantly if hydroquinone is no longer available.  Concerns regarding hydroquinone include ochronosis and carcinogenicity.  Despite the increased incidence of ochronosis in Africa, it remains an uncommon condition in the United States.  There are less than 35 reported cases despite the billions of units of product which have been sold in the United States.



Animal studies documenting hydroquinone related cancers are species and sex specific.  There are no documented cases of internal malignancies or skin cancers in humans treated hydroquinone formulations to lighten the skin.  In addition, epidemiological studies of people working in hydroquinone manufacturing plants for many years have shown no increase in malignancies. 



Hence, the current scientific data base shows that the benefits of hydroquinone substantially out ways any risks associated with its use. This drug should remain as an over the counter and prescription product without mandating new drug application (NDA).







Sincerely,



Pearl E Grimes, MD