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U.S. Department of Health and Human Services

Safety

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Sclerosol Intrapleural Aerosol (sterile talc) powder

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2012

Summary View

 

PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Studies on the carcinogenicity of talc have been performed using non-standard designs in which talc and its asbestos content were not fully characterized, preventing firm conclusions on its carcinogenicity. Tumor incidence in rats was not increased following either a single 20 mg injection with a 6 month recovery period or weekly injections of 25 mg for 4 weeks with an 84-week recovery period. Genotoxicity was assessed in cultures of rat pleural mesothelial cells (RPMC), as unscheduled DNA syntheses (UDS) and sister chromatid exchanges (SCEs). Asbestos-free talc was negative for genotoxicity under the conditions tested. No information is available on impairment of fertility in animals by talc.