Indocyanine green Pregnancy and Breastfeeding Warnings

Brand names: Cardio Green Kit, IC-Green, SPY Minimally Invasive Surgery (SPY-MIS) Kit, Spy Agent Green

Indocyanine green Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Risk summary: Malformative risk with the use of this drug in pregnant women is unlikely.

Animal studies have not been reported. There are no controlled data in human pregnancy; however, one small study suggested there is no placental transfer of this drug. Several literature studies over several decades have failed to reveal evidence of drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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

Indocyanine green 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

Further information

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

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