Rapaflo Pregnancy Warnings
Animal studies have failed to reveal evidence of teratogenicity or fetotoxicity. Studies in rats have revealed decreased male fertility at about twice the maximum recommended human dose (MRHE), decreased sperm count and viability at about 65 times the MRHE, and histopathological changes in the testes and epididymides at about 30 times the MRHE. Decreased fertility was reversible, and the clinical relevance is unknown. There are no controlled data in human pregnancy.
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 female patients.
US FDA pregnancy category: Not assigned.
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