Zofran Pregnancy Warnings
Use is not recommended (AU, UK)
This drug should be used during pregnancy only if clearly needed (US)
AU TGA pregnancy category: B1
US FDA pregnancy category: B
Comment:
-If use is absolutely necessary, caution should be exercised, especially during the first trimester.
Animal studies have failed to reveal evidence of harm to the embryo, fetus, gestation period, perinatal/postnatal development, and/or fertility. There are no controlled data in human pregnancy.
AU TGA pregnancy category B1: 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 have not shown 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.
See references