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lüll Genotoxic and carcinogenic effects of gastrointestinal drugs Brambilla G; Mattioli F; Martelli AMutagenesis 2010[Jul]; 25 (4): 315-26This review provides a compendium of retrievable results of genotoxicity and carcinogenicity assays performed on marketed gastrointestinal drugs. Of the 71 drugs considered, 38 (53.5%) do not have retrievable data, whereas the other 33 (46.5%) have at least one genotoxicity or carcinogenicity test result. Of these 33 drugs, 15 tested positive in at least one genotoxicity assay and 13 in at least one carcinogenicity assay; 8 of them gave a positive response in both at least one genotoxicity assay and at least one carcinogenicity assay. Concerning the predictivity of genetic toxicology findings for the result(s) of long-term carcinogenesis assays, of 21 drugs with both genotoxicity and carcinogenicity data: 6 (28.6%) are neither genotoxic nor carcinogenic, 2 (9.5%) tested positive in at least one genotoxicity assay but were non-carcinogenic, 5 (23.8%) tested negative in genotoxicity assays but were carcinogenic and 8 (38.1%) gave a positive response in at least one genotoxicity assay and in at least one carcinogenicity assay. Only 12 (16.9%) of the 71 drugs examined have all data required by present guidelines for testing of pharmaceuticals, but a large fraction of them were developed and marketed prior the present regulatory climate.|Carcinogenicity Tests[MESH]|Carcinogens/*toxicity[MESH]|Cell Transformation, Neoplastic/drug effects[MESH]|Consumer Product Safety[MESH]|Gastrointestinal Agents/*toxicity[MESH]|Humans[MESH]|Mutagenicity Tests[MESH]|Mutagens/*toxicity[MESH]|Neoplasms/chemically induced[MESH]|Risk Assessment[MESH] |