1978N-0065

Skin Bleaching Drug Products

FDA Comment Number :

EC118

Submitter :

Dr. Lauren Hughey

Date & Time:

12/07/2006 11:12:05

Organization :

UAB Dermatology

Category :

Health Professional

Issue Areas/Comments

GENERAL

I am a dermatologist in Birmingham, AL working at the University of Alabama at Birmingham. Our department serves a wide variety of patients- not only local but from a referral area including Tennessee, Georgia, Mississippi, and the panhandle of Florida. The patients are diverse including insured, uninsured, medicaid, medicare, light skin, dark skin, and everything in between. Hydroquinone is a product we recommend multiple times a day to our patients for many different pigmentary disorders of the skin. Most of our patients cannot afford the prescription strength hydroquinone, therefore, we often rely on the less expensive over-the-counter products to treat our patients. I have never had a patient have a side-effect or adverse reaction to the over-the-counter hydroquinone products. I feel they contribute significantly to the care of our patients and strongly oppose any move to make hydroquinone prescription only. Please see the below additional points.

Hydroquinone is one of the most effective molecules for the treatment of dark discoloration over the past 40-50 years and has been used in millions of people. It is used to treat the top concerns among our patients including melasma, photo-aging, post-inflammatory hyperpigmentation, medically and cosmetic disfiguring dyschromias.

Since 1961, hydroquinone has demonstrated a safe and effect profile among clinicians prescribing or recommending hydroquinone products. In spite of humans exposure to natural sources of hydroquinone in wheat, pears, berries, coffee, tea, onions, rice and red wine, there is not an association with carcinogenicity. There have been no reported cases of related malignancies in more than 50 years of manufacture and use of HQ.

Thank you for considering this information.

Lauren C. Hughey, M.D.