1978N-0065 Skin Bleaching Drug Products
FDA Comment Number : EC131
Submitter : Dr. Heather Woolery-Lloyd Date & Time: 12/08/2006 08:12:51
Organization : Dr. Heather Woolery-Lloyd
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I am a dermatologist in Miami specializing in ethnic skin. I practice at the University of Miami and am the Director of Ethnic Skin Care. Dyschromia and hyperpigmentation of the skin are the most common complaints in my patients. I treat hundreds of patients each month suffering from this condition. Dyschromia and post inflammatory hyperpigmentation can be a highly disfiguring condition that significantly impacts a patients quality of life. Hydroquinone is the only highy effective treatment for this condition. It has been used for over fifty years with very rare adverse effects. In fact there are few medications of any type on the market with such an excellent side effect profile. I urge your organization not to remove hydroquinone from the market. It will have the greatest impact on my patients (most frequently African Americans and Hispanics)who suffer from this condition. In this patient population, any irritation in the skin is frequently followed by hyperpigmntation in the skin. By removing hydroquinone, you would eliminate the main treatment for the most common skin complaint in African American and Hispanic patients. Please consider this information carefully. Dermatologists who prescribe hydroquinone daily have had no problems with this medication. There is absolutely no evidence that topical hydroquinone causes cancer in humans. Please do not remove this highly effective and safe medication form the market.