Bio-statin Pregnancy Warnings
Animal reproduction studies have not been conducted with this drug. There are no controlled data in human pregnancy and/or reproductive capacity.
AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
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.
Caution is recommended.
AU TGA pregnancy category: A
US FDA pregnancy category: C
See references
