Balversa Pregnancy Warnings
Use is not recommended.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on the mechanism of action and findings in animal reproduction studies, this drug can cause fetal harm when administered to a pregnant woman. Administration to pregnant animals during organogenesis caused malformations and embryofetal death at maternal exposures that were less than the human exposures at the maximum human recommended dose.
Comments:
-This drug can harm a developing fetus.
Recommendations:
-Advise pregnant women of the potential risk to the fetus.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Advise female patients of reproductive potential to use effective contraception during therapy and for one month after.
-Advise male patients with female partners of reproductive potential to use effective contraception during therapy and for one month after.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Based on findings from animal studies, this drug may impair fertility in females of reproductive potential.
Animal studies have revealed evidence of embryofetal death, major blood vessel malformations and other vascular anomalies, limb malformations (ectrodactyly, absent or misshapen long bones), an increased incidence of skeletal anomalies in multiple bones (vertebrae, sternebrae, ribs), and decreased fetal weight. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
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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