The safety of hydroquinone: a dermatologist's response to the 2006 Federal Register.
J Am Acad Dermatol
; 57(5): 854-72, 2007 Nov.
Article
en En
| MEDLINE
| ID: mdl-17467115
Recently, the US Food and Drug Administration proposed a ban on over-the-counter hydroquinone mainly on the basis of high absorption, reports of exogenous ochronosis in humans, and murine hepatic adenomas, renal adenomas, and leukemia with large doses over extended time periods. Systemic exposure to hydroquinone from routine topical application is no greater than that from quantities present in common foods. While murine hepatic adenomas increased, murine hepatocellular carcinomas decreased, suggesting a protective effect. Renal tumors are sex, species, and age specific and therefore do not appear relevant to humans after decades of widespread use. Murine leukemia has not been reproducible and would not be expected from small topical doses. Finally, a literature review of exogenous ochronosis and clinical studies employing hydroquinone (involving over 10,000 exposures under careful clinical supervision) reveal an incidence of exogenous ochronosis in the United States of 22 cases in more than 50 years. Therefore, the proposed ban appears to be unnecessarily extreme.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Pigmentación de la Piel
/
Hidroquinonas
Límite:
Animals
/
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
J Am Acad Dermatol
Año:
2007
Tipo del documento:
Article
País de afiliación:
Estados Unidos
Pais de publicación:
Estados Unidos