Andexxa Pregnancy Warnings
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned
Risk Summary: Insufficient data exists in pregnant women to inform patients of associated risks.
Animal studies have not been reported. There are no controlled data in human pregnancy.
Safety and effectiveness during labor and delivery have not been evaluated.
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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