Imdur Pregnancy Warnings
Use is recommended only if clearly needed and the benefit outweighs the risk.
AU TGA pregnancy category: B2
US FDA pregnancy category: C/B (manufacturer dependent)
Animal studies have failed to reveal evidence of teratogenicity. 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.
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.
See references
