Digoxin immune fab Pregnancy and Breastfeeding Warnings

Brand names: DigiFab, Digibind

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

Digoxin immune fab Pregnancy Warnings

This drug should be used only if clinically needed.

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

Animal studies have not been performed. There are no controlled data in human 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 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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