Estramustine Pregnancy Warnings
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 in women.
US FDA pregnancy category: Not Assigned
Comments:
-Although testing by the Ames method failed to demonstrate mutagenicity for this drug, it is known that both estradiol and nitrogen mustard are mutagenic.
-Some patients who had been impotent while on estrogen therapy have regained potency while taking this drug.
-Advise patients to use effective contraceptive measures due to the possibility of mutagenic effects.
See references
