Prempro Pregnancy Warnings
Animal studies have shown high doses of progestins can cause masculinization of the female fetus. 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 D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
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: D
US FDA pregnancy category: Not assigned
Risk Summary: This drug is not indicated for use in females of reproductive potential; there appears to be little or no increased risk of birth defects in women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy.
Comments:
-If pregnancy occurs, this drug should be discontinued.
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