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Ioversol Pregnancy and Breastfeeding Warnings

Ioversol is also known as: Optiray 160, Optiray 240, Optiray 300, Optiray 320, Optiray 350

Medically reviewed on April 10, 2018

Ioversol Pregnancy Warnings

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. It is not known whether this drug crosses the placental barrier or reaches fetal tissues. However, many injectable contrast agents cross the placental barrier in humans and appear to enter fetal tissue passively. Animal teratology studies are not always predictive of human response. There are no adequate and well controlled studies 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.

AU, US: Use is not recommended unless clearly needed.
UK: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

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

Comments: X-ray procedures involve a certain risk related to the exposure of the fetus.

See references

Ioversol Breastfeeding Warnings

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: Data not available

Comments: The effects in the nursing infant are unknown.

Many injectable contrast agents are excreted unchanged in breast milk to an amount of
approximately 1 % of the given dose.

See references

References for pregnancy information

  1. "Product Information. Optiray 350 (ioversol)." Mallinckrodt Medical Inc, St. Louis, MO.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Optiray 350 (ioversol)." Mallinckrodt Medical Inc, St. Louis, MO.

Further information

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

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