Uptravi Pregnancy Warnings
AU, UK: Use is not recommended.
US: The manufacturer makes no recommendation regarding use during pregnancy.
AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.
Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.
Comments: Use of adequate methods of contraception should be encouraged.
Animal studies have failed to reveal clinically relevant effects on embryofetal development and survival. A slight decrease in fetal and maternal body weight was observed in rats at doses approximately 47 times the maximum recommended human dose. 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
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