Imovax rabies (human diploid cell) Pregnancy Warnings
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: C
Comments:
-If there is substantial risk of rabies exposure, pre-exposure prophylaxis may be indicated.
-Because of the consequences of inadequately treated rabies exposure, pregnancy is not a contraindication to post-exposure prophylaxis.
Animal studies have not been conducted. There are no controlled data in human pregnancy. Limited data have not shown fetal abnormalities with rabies vaccination.
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.
See references