Amphotericin b liposomal Pregnancy and Breastfeeding Warnings

Brand names: AmBisome

Medically reviewed by Drugs.com. Last updated on Feb 16, 2024.

Amphotericin b liposomal Pregnancy Warnings

Safety has not been established during pregnancy; this drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B2
US FDA pregnancy category: B

Animal studies showed no teratogenicity, however at higher doses there was an increase in spontaneous abortions. There are no controlled data in human pregnancy. A small number of pregnant women have been successfully treated with amphotericin B deoxycholate without obvious effects on the fetus, however the number of cases is insufficient to draw conclusions about safety during pregnancy.

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 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.

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Amphotericin b liposomal Breastfeeding Warnings

Use is not recommended and 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:
-Decisions on whether to breastfeed should take into account the potential risk to the child as well as the benefit of treatment for the mother.

See references

Further information

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