Nipent Pregnancy Warnings
Use should be avoided.
US FDA pregnancy category: Not assigned.
Risk Summary: Animal studies have shown maternal toxicity, embryotoxicity, and teratogenicity.
Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Women of childbearing potential receiving this drug should be advised not to become pregnant.
-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.
Animal studies have revealed evidence of maternal toxicity, embryotoxicity, and teratogenicity. 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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