Biopatch Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: A
US FDA pregnancy category: C (periodontal chip)
US FDA pregnancy category: B (soap, solution, and oral rinse formulations)
Animal models have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy.
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 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.
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