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Epoprostenol Pregnancy and Breastfeeding Warnings

Brand names: Flolan, Veletri

Medically reviewed by Drugs.com. Last updated on Aug 25, 2023.

Epoprostenol Pregnancy Warnings

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

AU TGA pregnancy category: B1
US FDA pregnancy category: 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.

Comments: Limited data from case series and case reports have not established an association with major birth defects, miscarriage, or adverse maternal or fetal outcomes when this drug is used during pregnancy.

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 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.

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

See also

References for pregnancy information

  1. (2001) "Product Information. Flolan (epoprostenol)." Glaxo Wellcome
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. (2017) "Product Information. Epoprostenol Sodium (epoprostenol)." Teva Pharmaceuticals USA
  5. (2017) "Product Information. Veletri (epoprostenol)." Actelion Pharmaceuticals US Inc

References for breastfeeding information

  1. (2001) "Product Information. Flolan (epoprostenol)." Glaxo Wellcome
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
  5. (2017) "Product Information. Epoprostenol Sodium (epoprostenol)." Teva Pharmaceuticals USA
  6. (2017) "Product Information. Veletri (epoprostenol)." Actelion Pharmaceuticals US Inc

Further information

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

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