Oralair Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: B2
US FDA pregnancy category: B
Animal studies at doses up to 76 times the maximum clinical exposure have failed to reveal evidence of fetotoxicity. 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 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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