| 1978N-0065 | Skin Bleaching Drug Products | |||||||||||||||||||||||
| FDA Comment Number : | EC126 | |||||||||||||||||||||||
| Submitter : | Dr. Jonathan Winter | Date & Time: | 12/07/2006 11:12:09 | |||||||||||||||||||||
| Organization : | Dr. Jonathan Winter | |||||||||||||||||||||||
| Category : | Health Professional | |||||||||||||||||||||||
| Issue Areas/Comments | ||||||||||||||||||||||||
| GENERAL | ||||||||||||||||||||||||
| GENERAL | ||||||||||||||||||||||||
| I read your docket on hydroquinones, and as a Dermatologist who worked in the Bronx and now New Jersey for 20 years, I totally disagree with your conclusions. I have treated hundreds of patients with hydroquinones, some with "disfiguring" hyperpigmentation, and most of them improved significantly. There is no other topical or oral medication that is close to as effective. I have never had a patient develop severe or "disfiguring" ochronosis- I simply tell them to discontinue usage if they develop darkening of the skin, which in this country is a rare event indeed. The fact that a high percentage of patients in the bright sun of South Africa develop ochronosis has no relevance to my patients, as evidenced by the mere 16 case-study patients from the US that you could identify in your argument. These cremes have been used in millions of people in the US extensively for 40-50 years for sometimes disfiguring dyschromias, and you are concerned about a small handful of severe ochronosis cases? You greatly overestimate the incidence of this rare condition in this country. Have you asked clinical Dermatologists who recommend these cremes every day if this is truly a common problem in their offices?
Regarding malignant potential, I do not find the evidence convincing. Tumor development in lab animals required huge mg/kg doses that are not clinically relevant to the manner that these cremes are applied topically. If this were truly a problem in topical application in humans, why have we not had any reported cases in humans in 50 years of such extensive usage? If this ingredient is limited or removed, you will be limiting my best medication for mild, moderate, and severe hyperpigmentation. The benefits of this drug are not "low", and the risks over many, many years have proven to be minimal. Respectfully, Jonathan Winter, MD Head of Dermatology Division, Kennedy Hospital at Washington 100 Kingsway East, Suite A-1 Sewell, NJ 08080 | ||||||||||||||||||||||||