Xiaflex Pregnancy Warnings
Animal studies have failed to reveal evidence of fetal harm. 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.
Benefit should outweigh risk.
AU TGA pregnancy category: B1
US FDA pregnancy category: B
See references