title: Update of carcinogenicity studies in animals and humans of 535 marketed pharmaceuticals.
abstract: This survey is a compendium of information retrieved on carcinogenicity in animals and humans of 535 marketed pharmaceuticals whose expected clinical use is continuous for at least 6 months or intermittent over an extended period of time. Of the 535 drugs, 530 have the result of at least one carcinogenicity assay in animals, and 279 (52.1%) of them gave a positive response in at least one assay. Only 186 drugs (34.8%) have retrievable information on carcinogenicity in humans, and 104 of them gave to a variable extent evidence of a potential carcinogenic activity. Concerning the correlation between results obtained in animals and epidemiological findings, 58 drugs gave at least one positive result in carcinogenicity assays performed in animals and to a variable extent displayed evidence of carcinogenicity in humans, but 97 drugs tested positive in animals and were noncarcinogenic in humans or vice versa. Our findings, which are in agreement with previous studies, indicate that the evaluation of the benefit/carcinogenic risk ratio should be always made in prescribing a drug.
authors.affiliation: Department of Internal Medicine, Division of Clinical Pharmacology and Toxicology, University of Genoa, Viale Benedetto XV, 2, I-16132 Genoa, Italy. farmdimi@unige.it
authors.forename: Giovanni
authors.initials: G
authors.lastname: Brambilla
authors.forename: Francesca
authors.initials: F
authors.lastname: Mattioli
authors.forename: Luigi
authors.initials: L
authors.lastname: Robbiano
authors.forename: Antonietta
authors.initials: A
authors.lastname: Martelli
mesh_terms: D000818:Animals; D015197:Carcinogenicity Tests / Q000379:methods; D002273:Carcinogens / Q000633:toxicity*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D004364:Pharmaceutical Preparations
chemical_list: D002273:Carcinogens; D004364:Pharmaceutical Preparations