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Safety of ondansetron
1Glaxo Group Research Limited, Greenford, Middlesex, U.K.
European Journal of Cancer & Clinical Oncology
|January 1, 1989
Summary
Ondansetron is a safe and well-tolerated anti-emetic for cancer patients, with common side effects like constipation and headache being manageable. Animal studies and clinical use show a wide therapeutic index and no significant adverse events.
Area of Science:
- Pharmacology
- Clinical Toxicology
- Oncology
Background:
- Ondansetron is an anti-emetic medication used in cancer treatment.
- Previous animal studies suggested a favorable safety profile for ondansetron.
Purpose of the Study:
- To review the safety of ondansetron based on clinical experience.
- To evaluate adverse events associated with ondansetron in patients undergoing cancer treatment.
Main Methods:
- Review of safety data from approximately 1,400 cancer patients treated with ondansetron.
- Inclusion of data from 650 volunteers and patients with other medical conditions.
- Analysis of animal pharmacology and toxicology studies.
Main Results:
- Ondansetron demonstrated good tolerability in clinical use.
- The most frequent side effects were constipation and headache, which were not problematic for cancer patients.
- Increases in liver function tests were observed, comparable to metoclopramide and likely related to underlying conditions or chemotherapy.
- No end-organ toxicity or extrapyramidal side effects were reported.
Conclusions:
- Ondansetron is a well-tolerated anti-emetic with a wide therapeutic index.
- Clinical experience supports the safety of ondansetron for managing nausea and vomiting in cancer patients.
- The drug exhibits no dependence liability and minimal drug interactions.
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