For definition of Groups, see Preamble Evaluation.
VOL.: 50 (1990) (p. 293)
Chem. Abstr. Name: 2H-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-1,1-dioxide
Hydrochlorothiazide has been used extensively since 1957 as a diuretic and antihypertensive agent.
Hydrochlorothiazide was tested for carcinogenicity by oral administration in one strain of mice and one strain of rats. An increase in the incidence of hepatocellular adenomas was observed in male mice. No increase in the incidence of tumours at any site was observed in two studies in rats.
In one hypothesis-generating study in which many drugs were screened for possible carcinogenicity, associations with hydrochlorothiazide use were observed for cancers of the prostate and of all sites combined, which could have been accounted for by chance.
One study provided no evidence that use of hydrochlorothiazide in the first trimester of pregnancy is associated with the induction of birth defects. In rats, no teratogenic, embryotoxic or fetotoxic effect was observed.
Hydrochlorothiazide induced gene mutations in mouse lymphoma cells and sister chromatid exchange in Chinese hamster cells. It did not induce chromosomal aberrations in Chinese hamster cells in vitro or sex-linked recessive lethal mutations in Drosophila. Hydrochlorothiazide induced mitotic recombination and nondisjunction in Aspergillus nidulans. It was not mutagenic to Salmonella typhimurium or Escherichia coli.
There is inadequate evidence for the carcinogenicity of hydrochlorothiazide in humans.
There is inadequate evidence for the carcinogenicity of hydrochlorothiazide in experimental animals.
Hydrochlorothiazide is not classifiable as to its carcinogenicity to humans (Group 3).
For definition of the italicized terms, see Preamble Evaluation.
Last updated: 11 November 1997
See Also: Toxicological Abbreviations Hydrochlorothiazide (PIM 265)