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Mutagenic and leukemogenic activity of haloperidol: a negative study
H Van Cauteren1, P Vanparys, C de Meester
1Janssen Pharmaceutica N.V., Department of Toxicology, Beerse, Belgium.
Drug and Chemical Toxicology
|January 1, 1987
Summary
Haloperidol, a neuroleptic drug, was evaluated for its potential to cause mutations or leukemia. Studies found no evidence of mutagenic or leukemogenic effects, indicating safety in these aspects.
Area of Science:
- Pharmacology
- Toxicology
- Oncology
Background:
- Haloperidol is a widely used neuroleptic medication from the butyrophenone class.
- Assessing the mutagenic and leukemogenic potential of pharmaceuticals is crucial for drug safety.
Purpose of the Study:
- To investigate the mutagenic potential of haloperidol using in vitro bacterial assays.
- To evaluate the leukemogenic and carcinogenic effects of haloperidol in a long-term animal study.
Main Methods:
- In vitro mutagenicity testing using three variants of the Ames Salmonella/microsome assay.
- An 18-month carcinogenicity study in mice involving daily intraperitoneal injections of haloperidol.
Main Results:
- Haloperidol demonstrated no mutagenic activity in any Salmonella typhimurium strains across all tested assay variants.
- No leukemogenic or other carcinogenic effects were observed in mice following 18 months of haloperidol exposure.
Conclusions:
- Haloperidol is not mutagenic in the Ames Salmonella assay.
- Haloperidol does not exhibit leukemogenic or carcinogenic properties in mice based on this study.