Ioflupane I 123 Pregnancy and Breastfeeding Warnings

Brand names: DaTscan

Medically reviewed by Drugs.com. Last updated on Dec 11, 2023.

Ioflupane I 123 Pregnancy Warnings

Use is not recommended unless clearly needed.

US FDA pregnancy category: C

Comments: Assess for the presence of pregnancy prior to administering this drug to women of childbearing potential.

Animal reproductive and developmental toxicity studies have not been conducted. Like all radiopharmaceuticals, this drug has a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development, and the magnitude of the radionuclide dose. Administration of ioflupane I-123 at a dose of 185 MBq (5 mCi) results in an absorbed radiation dose to the uterus of 0.3 rad (3.0 mGy). Radiation doses greater than 15 rad (150 mGy) have been associated with congenital anomalies. Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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Ioflupane I 123 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.
-Consider interrupting nursing and pumping and discarding breast milk for 6 days after administration of this drug in order to minimize risks to a nursing infant.

See references

Further information

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