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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.

See references

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.

See references

References for pregnancy information

  1. Kingsbury AC "Danazol and fetal masculinization: a warning." Med J Aust 143 (1985): 410-1
  2. Schwartz R "Ambiguous genitalia in a term female infant due to exposure to danazol in utero." Am J Dis Child 136 (1982): 474
  3. Wentz AC "Adverse effects of danazol in pregnancy." Ann Intern Med 96 (1982): 672-3
  4. Quagliarello J, Greco MA "Danazol and urogenital sinus formation in pregnancy." Fertil Steril 43 (1985): 939-42
  5. Duck SC, Katayama KP "Danazol may cause female pseudohermaphroditism." Fertil Steril 35 (1981): 230-1
  6. Peress MR, Kreutner AK, Mathur RS, Williamson HO "Female pseudohermaphroditism with somatic chromosomal anomaly in association with in utero exposure to danazol." Am J Obstet Gynecol 142 (1982): 708-9
  7. Shaw RW, Farquhar JW "Female pseudohermaphroditism associated with danazol exposure in utero. Case report." Br J Obstet Gynaecol 91 (1984): 386-9
  8. Ronnberg L, Jarvinen PA "Pregnancy rates following various therapy modes for endometriosis in infertile patients." Acta Obstet Gynecol Scand Suppl 123 (1984): 69-72
  9. "Product Information. Danocrine (danazol)." Sanofi Winthrop Pharmaceuticals, New York, NY.
  10. Rosa FW "Virilization of the female fetus with maternal danazol exposure." Am J Obstet Gynecol 149 (1984): 99-100
  11. Castro-Magana M, Cheruvanky T, Collipp PJ, Ghavami-Maibodi Z, Angulo M, Stewart C "Transient adrenogenital syndrome due to exposure to danazol in utero." Am J Dis Child 135 (1981): 1032-4
  12. Brunskill PJ "The effects of fetal exposure to danazol." Br J Obstet Gynaecol 99 (1992): 212-5

References for breastfeeding information

  1. "Product Information. Danocrine (danazol)." Sanofi Winthrop Pharmaceuticals, New York, NY.

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