Genotoxicity and Carcinogenicity Studies of Bronchodilators and AntiAsthma Drugs

This survey is a compendium of genotoxicity and carcinogenicity information of bronchodilators and antiasthma drugs. Data from 46 marketed drugs were collected. Of these 46 drugs, 25 (54.3%) did not have retrievable genotoxicity or carcinogenicity data. The remaining 21 (45.7%) had at least one geno...

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Bibliographic Details
Published in:Basic & clinical pharmacology & toxicology 2013-05, Vol.112 (5), p.302-313
Main Authors: Brambilla, Giovanni, Mattioli, Francesca, Robbiano, Luigi, Martelli, Antonietta
Format: Article
Language:English
Subjects:
Animals
Biological and medical sciences
Bronchodilator Agents - toxicity
Carcinogenicity Tests - statistics & numerical data
Carcinogens - classification
Carcinogens - toxicity
Data Collection
Drug-Related Side Effects and Adverse Reactions
Guidelines as Topic
Medical sciences
Mice
Mutagenicity Tests - statistics & numerical data
Mutagens - classification
Mutagens - toxicity
Pharmaceutical Preparations - classification
Pharmacology. Drug treatments
Rats
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Summary:This survey is a compendium of genotoxicity and carcinogenicity information of bronchodilators and antiasthma drugs. Data from 46 marketed drugs were collected. Of these 46 drugs, 25 (54.3%) did not have retrievable genotoxicity or carcinogenicity data. The remaining 21 (45.7%) had at least one genotoxicity or carcinogenicity test result. Of these 21 drugs, 10 had at least one positive finding: three tested positive in at least one genotoxicity assay, eight in at least one carcinogenicity assay, and one of them gave positive results in both genotoxicity assay and carcinogenicity assay. Concerning the predictivity of genetic toxicology findings for the result(s) of long‐term carcinogenesis assays, 15 drugs had both genotoxicity and carcinogenicity data: seven of them (46.6%) were neither genotoxic nor carcinogenic, 6 (40.0%) were carcinogenic in at least one sex of mice or rats but tested negative in genotoxicity assays, 1 (6.7%) tested positive in genotoxicity assay but was non‐carcinogenic, and 1 (6.7%) gave positive responses in both genotoxicity and carcinogenicity assay. Only 11 (23.9%) of the 46 drugs considered had all data required by current guidelines for testing of pharmaceuticals, but a large fraction of them were developed and marketed prior to the present regulatory climate.
ISSN:1742-7835
1742-7843
DOI:10.1111/bcpt.12054