VOL.: 26 (1981) (p. 267)
Methotrexate can induce teratogenic effects in several species and embrolethality at doses nontoxic to the mother. In monkeys, only embryolethality was observed.
Methotrexate is mutagenic in mice in vivo. In various mammalian cells in culture the drug causes chromosomal aberrations and increases in sister chromatid exchanges. Methotrexate also induces morphological transformation in mouse cells.
Methotrexate is a human teratogen which causes a variety of malformations. It causes chromosomal aberrations in bone-marrow cells. No data were available to evaluate the mutagenic potential of this drug.
Methotrexate has been associated in case reports with a variety of subsequent neoplasms. One study of a defined group of patients, in which no expected numbers were presented, produced no suggestion of a cancer excess. The only other epidemiological study showed no excess of cancer in patients treated with methotrexate.
On the basis of the available data, no evaluation could be made of the carcinogenicity of methotrexate to humans.
Subsequent evaluation: Suppl. 7 (1987)
See Also: Toxicological Abbreviations