Bijuva Pregnancy Warnings
Epidemiologic studies and meta-analyses have not shown exposure to combined hormonal contraceptives (estrogen and progestins) increases the risk of genital or non-genital birth defects with exposure before conception or during pregnancy. This drug is not indicated for use in females of reproductive potential. 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
AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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 is not indicated for use during pregnancy
AU TGA pregnancy category: B3 (estradiol); category A (progesterone)
US FDA pregnancy category: Not assigned
Risk Summary: There are no data on use of this drug in pregnant women; this drug is not indicated for use in females of reproductive potential.
Comment:
-If pregnancy occurs, this drug should be withdrawn immediately.
See references
