The safety of hydroquinone: A dermatologist’s response to the 2006 Federal Register - 19/08/11
Abstract |
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.
Le texte complet de cet article est disponible en PDF.Abbreviations used : CPN, DESI, FDA, NDA, NTP, OTC, TFM
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Funding sources: None. |
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Disclosure: Dr Levitt is Vice President of Taro Pharmaceuticals U.S.A., Inc. and is also a major shareholder of its parent company, Taro Pharmaceutical Industries, Ltd (Taro). Taro manufactures and sells the Lustra (hydroquinone USP 4%) line of products. |
Vol 57 - N° 5
P. 854-872 - novembre 2007 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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