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Epoprostenol Pregnancy and Breastfeeding Warnings

Epoprostenol is also known as: Flolan, Veletri

Medically reviewed on April 13, 2018

Epoprostenol Pregnancy Warnings

Animal studies have failed to reveal evidence of impaired fertility or fetal harm. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B1
US FDA pregnancy category:
-Veletri(R): B
-Flolan(R): Not assigned

Risk Summary: Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death.

See references

Epoprostenol Breastfeeding Warnings

Caution is recommended.
-According to some manufacturers, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Flolan (epoprostenol)." Glaxo Wellcome, Research Triangle Park, NC.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Veletri (epoprostenol)." Actelion Pharmaceuticals US Inc, South San Francisco, CA.
  5. "Product Information. Epoprostenol Sodium (epoprostenol)." Teva Pharmaceuticals USA, North Wales, PA.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Flolan (epoprostenol)." Glaxo Wellcome, Research Triangle Park, NC.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Epoprostenol Sodium (epoprostenol)." Teva Pharmaceuticals USA, North Wales, PA.
  5. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  6. "Product Information. Veletri (epoprostenol)." Actelion Pharmaceuticals US Inc, South San Francisco, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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