1978N-0065 Skin Bleaching Drug Products
FDA Comment Number : EC135
Submitter : Dr. James Icken Date & Time: 12/11/2006 09:12:12
Organization : American Academy of Dermatology
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Unless you are in possession of clinical human trials that definitively show a direct link between hydroquinone and development of cancer, you will be wrong to remove this therapeautic agent from the market. Hydroquinone is the best agent we have to safely treat patients with disorders of hyperpigmentation. This drug has a long track record of safety and effectiveness in human clinical practice. For patients with disorders of hyperpigmentation this drug is a godsend. In my 15 years of clinical dermatology practice I have never seen a case of exogenous ochronosis related to the use of hydroquinone, nor have any of my partners. The cases of this entity that have appeared in the literature have been from foreign countries in patients who have used higher concentrations of hydroquinone for many years. We just don't see this in our patient population. Thank you for your kind attention.