Brilinta Pregnancy Warnings
AU and UK: Use is not recommended.
US: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
AU TGA pregnancy category: B1
US FDA pregnancy category: C
Comments: Use of adequate methods of contraception should be encouraged.
Animal studies have revealed structural abnormalities, reproductive toxicity, and fetolethality. 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 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