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Generic Name
Cyproterone acetate and Ethinylestradiol
Trade Name
Diane - 35
Risk Category
X
  • Positive evidence of human fetal risk exists.
  • Potential benefits may warrant use of the drug in pregnant women despite potential risks (e.g. life threatening situations or serious illness).
  • Studies in animals and/or humans have demonstrated fetal abnormalities.
  • Fetal risk involved in use of drug, clearly outweighs potential benefit.
  • Contraindicated in women who are or may become pregnant. Don’t use.
FDA Pregnancy Risk Categories

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Indication
Indication
  • Antiandrogen with estrogenic hormone for treatment of hirsutism.
  • Fetal Risk
    Fetal Risk
  • Cyproterone is carcinogenic in animals producing hepatic tumors.
  • It causes feminization of male fetuses if used any time during pregnancy.
  • Exposure to estrogens in general in 1st trimester has been reported to cause congenital anomalies including eye, ear, cardiovascular defects and Down's syndrome.
  • Use of estrogenic hormones is contraindicated in pregnancy.
  • Breast Feeding
    Breast Feeding
  • Cyproterone and ethinylestradiol are excreted into milk.
  • Cyproterone should be used with caution because of possible anti-androgen effects in the newborns.
  • Estrogens decrease milk production.
  • Other Trade Names
     
    The information on this Web site is not intended as a substitute for the advice and care of your doctor or other health-care provider. Always consult your doctor if you have any questions about exposures during pregnancy and lactation, and before you take any medications. Please read the Terms and Conditions before using this website.
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