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Danazol Pregnancy and Breastfeeding Warnings

Danazol is also known as: Danocrine

Danazol Pregnancy Warnings

Danazol has been assigned to pregnancy category X by the FDA. Animal (rat) studies using danazol at doses 7 to 15 times that of a corresponding human dosage on days 6 to 15 of gestation failed to reveal evidence of teratogenicity or embryotoxicity. Studies in rabbits during days 6 to 18 of gestation at doses 2 to 4 times that of a corresponding human dosage resulted in inhibition of fetal development. There are no controlled data in human pregnancy. Danazol use is considered contraindicated during pregnancy. Reversible oligospermia may occur in adult males after prolonged administration or excessive dosage. If this effect occurs, danazol can be discontinued and if restarted, a lower dosage should be utilized.

If therapy is not initiated during menstruation, a sensitive pregnancy test that detects early pregnancy should be done to determine that the patient is not pregnant. A non-hormonal contraceptive method should be used during danazol therapy. If pregnancy occurs during therapy, danazol should be discontinued. Patients should be advised of the possible risks to the fetus.

Danazol Breastfeeding Warnings

There are no data on the excretion of danazol into human milk. Breast-feeding is considered to be contraindicated by the manufacturer.

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