Defitelio Pregnancy Warnings
Animal studies have revealed a decreased number of implantations and viable fetuses. Assessment of embryofetal toxicity could not be completed in rats or rabbits due to high maternal mortality, abortion, and fetal resorption at all doses. 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.
UK: Use is not recommended unless clearly needed.
US: The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned
Risk Summary: No data exists regarding use of this drug in pregnant women. Advise pregnant women of the potential risk of miscarriage.
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