1978N-0065

Skin Bleaching Drug Products

FDA Comment Number :

EC105

Submitter :

Dr. Stanley Skopit

Date & Time:

12/06/2006 09:12:20

Organization :

A Center for Dermatology, PA

Category :

International Public Citizen

Issue Areas/Comments

GENERAL

I would like to protest the proposed withdrawal by the FDA of hydroquinone (HQ) in over-the-counter and most prescription formulations. HQ has been used in humans for disfiguring pigmentary disorders for over 40 years without a single case of skin cancer or internal malignancy related to its topical application. Ochronosis from HQ is rare, and mainly occurs in countries where high concentrations are available without prescription and in combination with resorcinol and hydroethanolic compounds, which may permit enhance absorption of HQ. I have a busy dermatology practice and I have rarely seen a case of ochronosis due to HQ. Several studies of workers who are exposed to large amounts of HQ in factories which process HQ for industrial use have found similar rates of mortality, cancer prevalence and work absences compared to workers in other occupations. In addition, HQ is ubiquitous and is found in common foods we eat every day, such as coffee, tea, wheat, pears and berries without any associated adverse effects.

A large number of patients will be adversely affected by a ban of HQ. This compound is the most effective depigmenting agent available and is used by millions of people worldwide for disfiguring pigmentation. Melasma, a disorder manifested by large dark patches on the cheeks, forehead and chin, is common, especially among people with brown skin. One study found that 8.4% of Hispanic women living in the U.S. had melasma. These patients have also demonstrated that melasma causes a significant effect on their quality of life in recent studies, particularly on emotional well-being, social life and sexual relationships. Hydroquinone is an effective treatment for melasma, and can significantly improve the quality of life for patients who suffer from this disorder. Post-inflammatory hyperpigmentation (PIH) is even more common than melasma, particularly from acne, which can leave pigmented spots for months to years after the initial lesions resolve. Countless patients use HQ to treat the disfiguring pigmentation left over from various inflammatory conditions. Patients with both melasma and PIH would suffer if HQ were to be removed from OTC and most prescription formulations. While additional studies outlined in the Federal register to investigate HQ further are warranted, the benefit/risk ratio clearly weighs in favor of continued use of HQ while these studies are being done. There is a benefit to physical and emotional health as a result of using HQ for pigmentary disorders. The alternatives to HQ are much less effective and often useless for these disorders. I urge the FDA to allow the continued use of hydroquinone in OTC and most prescription formulations.