DRUG INTERACTIONS
Carcinogenesis, Mutagenesis, Impairment of Fertility
There was no evidence of a tumorigenic effect in a 79-week oral chronic toxicity study in rats at doses up to 45 times the human dose.
Ethacrynic acid had no effect on fertility in a two-litter study in rats or a two-generation study in mice at 10 times the human dose.
Pregnancy
Pregnancy Category B
Reproduction studies in the mouse and rabbit at doses up to 50 times the human dose showed no evidence of external abnormalities of the fetus due to EDECRIN.
In a two-litter study in the dog and rat, oral doses of 5 or 20 mg/kg/day (2½ or 10 times the human dose), respectively, did not interfere with pregnancy or with growth and development of the pups. Although there was reduction in the mean body weights of the fetuses in a teratogenic study in the rat at a dose level of 100 mg/kg (50 times the human dose), there was no effect on mortality or postnatal development. Functional and morphologic abnormalities were not observed.
There are, however, no adequate and well-controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, EDECRIN should be used during pregnancy only if clearly needed.
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