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Generic Name
Acenocoumarol (nicoumalone)
Trade Name
Sintrom
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
  • A coumarin derivative oral anticoagulant for prophylaxis and treatment of thromboembolic complications.
  • Fetal Risk
    Fetal Risk
  • Crosses the placenta.
  • Contraindicated in pregnancy mainly the first trimester due to the characteristic congenital defects: Severe nasal hypoplasia, stippled epiphyseal calcifications, mental retardation, blindness, congenital cardiac defects and polydactyly.
  • If used in pregnancy, it should be discontinued at 37 wks due to the potential of maternal, fetal and neonatal hemorrhagic complications.
  • Breast Feeding
    Breast Feeding
  • Excreted into breast milk.
  • No adverse effects reported.
  • 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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