1978N-0065 Skin Bleaching Drug Products
FDA Comment Number : EC124
Submitter : Dr. Dreama Pilcher Date & Time: 12/07/2006 11:12:51
Organization : Dr. Dreama Pilcher
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
As a dermatologist, I am alarmed that the FDA would removed a product that is so effective and safe for the treatment of hyperpigmentation. The product has been available for almost 50 years and to my knowledge there are no reports of malignancies associated with hydroquinone usage. Ochronosis is very rare with HQ use and almost only seen in darker skin individuals. They can be monitored or a warning placed on over the counter products to discontinue usage if they observe a darkening of their skin. I discuss this with all patients on HQ treatment even though it is very rare. I personally use HQ daily for photoaging and I would continue to use it personally if it was removed from the market if I could purchase it. There is no treatment more effective. Do not overreact when there is no scientific basis! Dreama Pilcher drdreama@bellsouth.net