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Pentosan polysulfate sodium Pregnancy and Breastfeeding Warnings

Pentosan polysulfate sodium is also known as: Elmiron

Medically reviewed on Dec 15, 2017

Pentosan polysulfate sodium Pregnancy Warnings

Animal studies with the oral formulation have not been reported. Reproduction studies with IV daily doses did not reveal evidence of impaired fertility or fetal harm. Direct in vitro bathing in mouse embryos may cause reversible limb bud abnormalities. 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.

Use is not recommended unless clearly needed.

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

See references

Pentosan polysulfate sodium Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Elmiron (pentosan polysulfate sodium)." Baker Norton Pharmaceuticals, Miami, FL.
  3. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."

References for breastfeeding information

  1. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."
  2. "Product Information. Elmiron (pentosan polysulfate sodium)." Baker Norton Pharmaceuticals, Miami, FL.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

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