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Executive Summary

CIMETIDINE, CHLORPROPAMIDE, & DIAZEPAM LITERATURE EVALUATION for possible carcinogenic and genotoxic effects was recommended by the Federation of Assns. for Experimental Biology (FASEB) in a recently released interim report to the Natl. Cancer Institute (NCI). The three drugs were among 51 pharmaceutical and cosmetic compounds for which the group urged further evaluation (for list of drug and pharmaceutic aids for which further evaluation is recommended, see box below). The agents were chosen from a group of drugs and cosmetics provided by NCI. The FASEB review is based on draft monographs, prepared by the institute of toxicity data and data base searches. The FASEB document, dated April 2, provides an update on the panel's first year of work in evaluating the evidence of carcinogenicity and genotoxicity of 64 cosmetic ingredients and 109 drugs under a contract with NCI. The contract became effective in April 1983. The report generally provides an interim categorization of the substances provided by NCI for review. Ingredients selected first were those for which adequate data or sufficient reason provided a basis ford the conduct of evaluation, FASEB explained. According to FASEB, the interim scientific report represents "the first step in the process of providing NCI with a data base on possible carcinogenicity and genotoxicity of drugs and cosmetic ingredients which will be available to scientists, govt. agencies, industry, and other interested parties." The summary report on chlorpropamide, for example, cites NCI bioassay results from studies conducted in 1979, mutagenic studies in various cell assay systems, and a literature search of Toxline. The FASEB group said it found "adequate" evidence of animal carcinogenicity in two drugs, ethinyl estradiol and grieseofulvin, and rodent carcinogenicity in "components or metabolites" of D&C Reds 9 & 19. FASEB emphasized that the conclusions reached in the report are "working models subject to modification in format and scientific content prior to final submission to NCI in March 1985, after assessment of any additional relevant information and data obtained by the Expert Panel." The report also cautioned that the recommendations made are the views of the organization's Expert Panel, and not necessarily FASEB's. DRUGS & PHARMACEUTIC AIDS RECOMMENDED FOR CARCINOGENICITY & GENTOXICITY REVIEW BY FASEB Data extracted and compiled by "The Pink Sheet" from a recently released FASEB Interim Scientific Report on "Evaluation of the Evidence of Carcinogenicity and Genotoxicity of Drugs and Cosmetic Ingredients." Recommendations listed are subject to change. Acetaminophen Acronine Chloramphenicol Chlordiazepoxide Chlordiazepoxide HCI Chlorquine Chlropropamide Cimetidine Codeine Codeine Phosphate Coumarin Daunorubicin D&C Red 9 D&C Red 17 D&C Red 19 Diazepam Dimethyl sulfoxide Diphenhydramine HCI Disulfiram Doxorubicin Epinephrine HCI Ethinyl Estradiol Gentian Violet Griseofulvin Hexachlorophene Hydroxyurea Mechlorethamine Mechlorethamine HCI Melphalon Methltestosterone Metronidazole Nitromycin C Niridazole Nitrofurantoin Nitrofurazone Oxymethalone 8-Oxypurinolone Phenobarbital Phenobarbital sodium Phenytoin Pyrazinamide Streptozocin Theobromine Theophylline Triethanolamine

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