Oxycontin - Side Effects & Drug Interactions

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Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of oxycodone to evaluate its carcinogenic potential have not been conducted. Oxycodone was not mutagenic in the following assays: Ames Salmonella and E. coli test with and without metabolic activation at doses of up to 5000 µg, chromosomal aberration test in human lymphocytes in the absence of metabolic activation at doses of up to 1500 µg/ mL and with activation 48 hours after exposure at doses of up to 5000 µg/ mL, and in the in vivo bone marrow micronucleus test in mice (at plasma levels of up to 48 µg/ mL). Oxycodone was clastogenic in the human lymphocyte chromosomal assay in the presence of metabolic activation in the human chromosomal aberration test (at greater than or equal to 1250 µg/ mL) at 24 but not 48 hours of exposure and in the mouse lymphoma assay at doses of 50 µg/ mL or greater with metabolic activation and at 400 µg/ mL or greater without metabolic activation.