Bicalutamide Pregnancy Warnings
Use is contraindicated.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: This drug is contraindicated in females. This drug is contraindicated in pregnant women because it can cause fetal harm.
Comments:
-This drug is contraindicated in pregnancy.
-This drug can harm a developing fetus.
-Antiandrogen therapy may cause morphological changes in spermatozoa.
-Based on findings in animal reproduction studies and its mechanism of action, advise male patients with female partners of reproductive potential to use effective contraception during therapy and for 130 days after.
-Based on animal studies, this drug can lead to inhibition of spermatogenesis and may impair fertility in males of reproductive potential. The long-term effects on male fertility have not been studied.
In animal reproduction studies when this drug was given during organogenesis it caused abnormal development of reproductive organs in male fetuses at exposures approximately 0.7 to 2 times the human exposure at the recommended dose. 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.
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