Flomax Pregnancy Warnings
This drug is not indicated for use in female patients.
AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned.
Risk Summary: This drug is not indicated for use in female patients. There are no adequate data on the developmental risk associated with the use of it in pregnant women. No adverse developmental effects were observed in animal studies in which it was administered to rats or rabbits during the period of organogenesis.
Comments:
-This drug is not indicated for use in women.
-Female fertility in animal studies was significantly reduced, considered to be due to impairment of fertilization.
-Abnormal ejaculation including ejaculation failure, ejaculation disorder, retrograde ejaculation, and ejaculation decrease has been associated with this drug.
-Animal studies revealed significantly reduced fertility in males considered to be due to impairment of ejaculation, which was reversible.
Animal studies during the period of organogenesis at dose levels up to approximately 50 times the human therapeutic exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. There are no controlled data in human pregnancy.
AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
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.
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