Ondansetron: pre-clinical safety evaluation
Tucker, M.L.; Jackson, M.R.; Scales, M.D.; Spurling, N.W.; Tweats, D.J.; Capel-Edwards, K.
European Journal of Cancer and Clinical Oncology 25(Suppl 1): S79-S93
1989
ISSN/ISBN: 0277-5379 PMID: 2533905 Document Number: 4397
A programme of pre-clinical safety evaluation of ondansetron has been undertaken which involved a series of studies - single dose studies, repeat dose studies, reproduction studies, genotoxicity studies, oncogenicity studies, local irritancy studies, and a hypersensitivity study. Ondansetron was found to have a very good safety profile, and the only toxicity identified was associated with central nervous system activity when near lethal doses were administered. It was not genotoxic and had no reproductive or oncogenic potential. The comprehensive range of studies performed with ondansetron confirm its safety. The only significant toxicity to be identified was associated with central nervous system activity at near lethal levels. No morphological changes were detected in the brain and no other target organ toxicity was identified. Intravenous administration is well tolerated at the concentrations intended for clinical use. Ondansetron is not genotoxic in a wide range of tests and poses no reproductive or oncogenic hazard. In addition, ondansetron has no skin sensitising potential.
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