DRUG INTERACTIONS
D. Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term intramuscular administration of MPA has been shown to produce mammary tumors in beagle dogs. There was no evidence of a carcinogenic effect associated with the oral administration of MPA to rats and mice. Medroxyprogesterone acetate was not mutagenic in a battery of in vitro or in vivo genetic toxicity assays.
Medroxyprogesterone acetate at high doses is an antifertility drug and high doses would be expected to impair fertility until the cessation of treatment.
Long-term continuous administration of estrogen plus progestin therapy, has shown an increased risk of breast cancer and ovarian cancer. (See WARNINGS and PRECAUTIONS.)
E. Pregnancy
Pregnancy Category X
MPA tablets should not be used during pregnancy. (See CONTRAINDICATIONS.)
There may be increased risks for hypospadias, clitoral enlargement and labial fusion in children whose mothers are exposed to MPA tablets during the first trimester of pregnancy. However, a clear association between these conditions with use of MPA tablets has not been established.
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