Drospirenone and estradiol Pregnancy Warnings
Animal studies showed drospirenone crossing the placenta and entering the fetus with oral administration. A dose dependent increase in embryolethality due to pre- and post-implantation losses was seen in animals. Dose dependent feminization of male fetuses and virilization of female fetuses was seen with a combination of predrospirenone and ethynylestradiol in the last third of pregnancy; effects on males were seen at 12 to 20 times the human dose; effects on females were seen at 3 to 8 times the human dose. There are no controlled data in human pregnancy. Epidemiological studies have not shown increased birth defects with combined oral contraceptive use prior to pregnancy, or increased teratogenicity when inadvertently taken during early pregnancy.
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.
Use is contraindicated. (AU, US)
Use is not indicated. (UK)
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned
Comments:
-Rule out pregnancy before starting therapy.
-Discontinue this drug promptly if pregnancy occurs.
-There is little or no increased risk of birth defects when estrogens and progestins as an oral contraceptive are inadvertently used during early pregnancy.
See references
