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Fact sheet: the Report on Carcinogens - 9th edition

oved by the FDA for treatment of breast cancer, for reducing the incidence of contralateral breast cancer in women with a previous diagnosis of breast cancer, and for decreasing the risk of breast cancer in women who have a high risk of getting breast cancer. At the time of this drug's approval for reducing the risk of breast cancer, it was known that women who take tamoxifen have an increased risk of getting uterine cancer. FDA approved tamoxifen for use in women with a high risk of breast cancer because the benefit of decreasing the risk of breast cancer outweighed the risks of taking tamoxifen, including the risk of getting uterine cancer.

There has been concern expressed that the listing of tamoxifen in the 9th Report could raise concerns among patients regarding its use for cancer treatment or prevention. It is, therefore, important to again note that these listings do not address potential benefits of exposures to certain carcinogenic substances. In this instance, the benefits of exposure to the substance have been determined by the FDA to outweigh the risks entailed. Personal decisions concerning voluntary exposures to carcinogenic agents need to be based on additional information that is beyond the scope of the 9th Report. It is very important that the public and physicians be aware of potential risks so that they have the necessary knowledge to weigh the benefits versus risks of using tamoxifen.

Added as "reasonably anticipated to be human carcinogens" in the 9th Report:

  • Diesel exhaust particulates - Diesel exhaust particulates are listed in the 9th Report as "reasonably anticipated to be a human carcinogen." These particulates are generated in diesel exhaust, which is a complex mixture of combustion products of diesel fuel, with the exact composition depending on the type of engine, the speed and load at which it is run, and the composition of the fuel used. The Report states the listing is based on limited findings of e
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Contact: Sandra Lange
lange@niehs.nih.gov
919-541-0530
NIH/National Institute of Environmental Health Sciences
14-May-2000


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