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Does Photosensitivity Predict Photococarcinogenicity?

Division of Dermatologic and Dental Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD, USA

Javier Avalos

Division of Dermatologic and Dental Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD, USA

Paul Brown

Division of Dermatologic and Dental Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD, USA

Jonathan Wilkin

Division of Dermatologic and Dental Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD, USA

Assessment of short-term and long-term effects of light (pho—totesting) is part of the safety evaluation of drugs. Results are incorporated into drug package inserts to advise patients and health care providers about the use of drug products on sun—exposed skin. We undertook an exhaustive literature search and a search of archived studies at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), in order to evaluate the potential of short—term photoassays to predict long—term effects of drugs used in sunlight (280–700 nm). The correlation between the findings from the photococarcinogenicity assays in mice that used exposure to simulated sunlight and those from photogenotoxicity and photosensitivity studies was examined. Results indicated that photosensitivity and photogenotoxicity assays did not necessarily predict effects in photococarcinogenicity studies in mice. Effects of drugs on skin that are not due to photoactivation of drug can be important factors in enhancement of UV—induced skin carcinogenesis.

Key Words: Drug Safety • Photosensitivity • Photogenotoxicity • Photococarcinogenicity

International Journal of Toxicology, Vol. 18, No. 3, 191-198 (1999)
DOI: 10.1080/109158199225486


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