Animal studies have revealed decreased implantations and live fetuses at a dose more than 30 times the maximum recommended human dose (MRHD) on a mg/m2 basis. 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.

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.

This drug should be used during pregnancy only if clearly needed; safety has not been established during pregnancy, but this drug has been used without apparent harmful effects.

AU TGA pregnancy category: B1
US FDA pregnancy category: B (IV); Not assigned (oral).

See references

Caution is recommended; per some authorities, this drug should only be used if clearly needed.

Excreted into human milk: Yes (at levels approximately 6% of plasma concentrations)

Comments: The effects in the nursing infant are unknown; monitor for bruising and bleeding.

See references